Medtronic FlexCath Advance 4FC12 User Manual

Urgent Field Safety Notice

FlexCath Advance™ Steerable Sheath - Model Number 4FC12

Instructions For Use Update

October 2017

Medtronic reference: FA788

Dear Risk Manager,

This notification is to provide you with important information regarding an update to the Medtronic FlexCath
Advance Steerable Sheath, Model 4FC12, Instructions for Use (IFU) manual. This IFU revision incorporates
current best practices for minimizing the potential for air ingress and the risk of air embolism. This IFU update is
not in response to a device design deficiency, device malfunction, or a change in reported field performance
data.

Issue Description

Air embolism is a known risk for patients undergoing percutaneous interventions requiring access to the left
atrium, such as ablation procedures. According to the 2017 HRS/EHRA/ECAS/APHRS/ SOLAECE Expert
Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, “the most common cause of air
embolism is introduction of air via the transseptal sheath.”1

Medtronic has supplemented the FlexCath Advance Steerable Sheath IFU to highlight the known risk of air
embolism more prominently. These updates do not impact current clinical practice as this information is
consistent with current training and education materials, and with recommendations from HRS, JHRS, and
EHRA. This letter contains a summary of the IFU updates.

Medtronic is not retrieving product from the field. There are no changes to the management of patients who
have been or will be ablated with a system using a FlexCath Advance Steerable Sheath.

FlexCath Advance Steerable Sheaths remain available. FlexCath Advance Steerable Sheaths packaged with the
updated IFU will be shipped after any local regulatory approvals are obtained for the IFU updates.

Customer Actions

Please complete the following actions:

• Review the IFU Update Summary regarding air ingress and air embolism as provided in this letter.

• Please share this information with clinicians in your hospital that use the FlexCath Advance Steerable

Sheath. Also share this information with any other organization where these devices may have been
transferred.

• Please maintain a copy of this notice in your records.

IFU Update Summary

The FlexCath Advance Steerable Sheath IFU update includes the following additional language emphasizing
minimization of catheter exchanges, proper aspiration and flushing techniques, and slow advancement and
withdrawal of catheters through the sheath:

• Warnings and Precautions: Updated key language includes:
o Air aspiration – Remove the guide wire and dilator from the sheath or insert the catheter into

the sheath before slowly aspirating and flushing the sheath. This action minimizes the
aspiration of air through the valve of the sheath. Minimize catheter exchanges and always
advance and withdraw catheters through the valve slowly. Follow advancement or withdrawal

1

Calkins H, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial

Fibrillation. Heart Rhythm. (2017), doi 10.1016/j.hrthm.2017.05.012

of catheters with appropriate aspiration and flushing according to institutional standards or
consensus statements.

o Air embolism risk – Introducing any catheter or sheath into the circulatory system entails the

risk of air embolism, which can occlude vessels and lead to tissue infarction with serious
consequences. To minimize the risk of air embolism, observe and remove any air prior to
introducing the sheath and during the procedure. Minimize catheter exchanges and always
advance and withdraw catheters through the valve slowly. Follow advancement or withdrawal
of catheters with appropriate aspiration and flushing according to institutional standards or
consensus statements.

o Frequent flushing – Continuous drip and/or regular aspiration and flushing of the sheath and

dilator lumen are recommended:

 To minimize blood stagnation, clots, emboli and serious patient injury.
 After each contrast injection, to prevent contrast solution from sticking inside the

lumen.

o Back-bleeding – To minimize unintended back-bleeding through the side port, make sure the

stopcock is in a closed position after aspiration or flushing. Connecting to a continuous drip
provides forward flow, which can minimize back-bleeding.

o Side port aspiration – Infusion through the side port should only occur after all air is removed

from the unit. Aspirate the sheath according to institutional standards or consensus
statements.

• Adverse Events: Updated key language includes:
o Air embolism, a known risk, was added to the list of potential Adverse Events. Adding this to

the list of Adverse Events in the IFU does not change or impact current clinical practice.

The FlexCath Advance Steerable Sheath IFU update includes current procedural best practice and is
provided below for reference:

NOTE: Before introducing the sheath into the patient, test the deflection mechanism to ensure that it is
operational.

1. Assemble the sheath and dilator together.

o Flush the sheath side port and dilator lumen with sterile saline solution.
o Ensure that the sheath is in the neutral (non-deflected) position and wet the dilator shaft with

sterile saline solution.

o Insert the distal tip of the dilator straight through the center of the valve and fully into the

sheath until the dilator hub snaps into the sheath hub.

o Wet the shaft of the catheter with sterile saline solution.

2. Using an aseptic technique, create a vascular access with an appropriate introducer.

3. After access, administer anticoagulation therapy during and post-procedure according to
institutional standards.

4. Insert a compatible guide wire (see Chapter 7, “Specifications”, page 5) through the vasculature
and position the guide wire using standard vascular access techniques.

5. Insert the dilator and sheath over the guide wire and advance into the desired position.

6. Slowly remove the guide wire and dilator from the sheath. Slowly aspirate blood through the side
port and then flush the sheath, taking care to prevent bubbles.

7. Once the sheath is positioned, manage flushing and/or continuous drip according to institutional
standards or consensus statements.

8. Insert and position the catheter. Slowly aspirate and flush the sheath.

9. Prior to sheath withdrawal, ensure that the sheath is in the neutral (non-deflected) position.

10. Slowly withdraw the sheath from the body and obtain appropriate hemostasis according to
institutional standards or consensus statements.

The Competent Authority of your country has been notified of this action.

We are committed to patient safety and welcome any questions you may have regarding this communication.
Please contact your Medtronic representative at <XXXX> for any questions.

Sincerely,