MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY MRI; DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES

Model Number 7741

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this right atrial (ra) lead was an attempted implant due to poor parameters and helix extension difficulty.This ra lead was removed prior to pocket closure.No adverse patient effects were reported.

Event Description

It was reported that this right atrial (ra) lead was an attempted implant due to poor parameters and helix extension difficulty.This ra lead was removed prior to pocket closure.No adverse patient effects were reported.

Manufacturer Narrative

This lead was returned to boston scientific's post market quality assurance laboratory with the helix mechanism in a retracted position.Visual inspection found dried blood around the helix.Subsequent testing did not identify any product abnormalities that may have caused or contributed to the reported clinical observations.Laboratory analysis was unable to conclusively determine the root cause of the reported helix extension/retraction problems.The ingevity mri-compatible lead was designed with a goal of balancing multiple design inputs, including implant handling and short and long term safety performance (e.G., low dislodgement and perforation occurrence).The single filar inner coil design of the ingevity lead was selected for improved fatigue durability and for safe performance within an mri environment (protective against lead heating).Physician implant technique and patient anatomy may contribute to helix extension difficulty.Specifically, tortuous patient anatomy or bends in the proximal portion of the lead remaining outside of the body, sharp bends in the stylet, and/or kinks in the lead introducer sheath may contribute to situations where adequate torque is not transferred to the helix to enable extension/retraction.Implant techniques such as under-rotating or over-rotating the terminal tool, failure to remove the terminal tool between extension/retraction cycles to release torque stored in the inner coil, excessively fast tool rotation speed (>1 full turn per second), and the presence of tissue in the helix, which may accumulate with multiple lead repositioning attempts may also contribute to situations where adequate torque is not transferred to the helix to enable extension/retraction.Approved instructions for use provided with all products includes best practices and clear guidance to mitigate these potential contributing factors.

• Brand Name: INGEVITY MRI
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8545962
• MDR Text Key: 142957779
• Report Number: 2124215-2019-07432
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526523458
• UDI-Public: 00802526523458
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: 7741
• Device Catalogue Number: 7741
• Device Lot Number: 905311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1