MAUDE Adverse Event Report: CPI - DEL CARIBE INGEVITY; IMPLANTABLE LEAD

Model Number 7741

Device Problems Capturing Problem (2891); Device Contamination With Biological Material (2908); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that when implanting this right ventricular (rv) lead the helix was extended, but the pacing thresholds were high thus the lead was repositioned two times.The helix was extended a third time but the lead had dislodged.The helix was then attempted to be retracted, but it was not possible to retract.When the rv lead was removed tissue was seen in the helix mechanism, thus a new lead was used with no issues.This rv lead will be returned.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 an extended position.Visual inspection found dried blood/tissue 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 lead also passed electrical testing.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
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7436532
• MDR Text Key: 105685443
• Report Number: 2124215-2018-07003
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7741; L310
• Patient Age: 90 YR