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

Model Number 7741

Device Problems Difficult To Position (1467); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

This ingevity 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/tissue around the helix.Subsequent electrical and mechanical 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.Several implant technique and product design factors may contribute to helix extension/retraction difficulties, including: tortuous patient anatomy or bends in the proximal portion of the lead remaining outside of the body, sharp bends in the stylet, kinks in the lead introducer sheath, 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.In addition, the ingevity lead was designed with single filar inner and outer coils for improved flex fatigue and for better performance within an mri environment, with multiple layers of insulation between the conductors for long-term reliability.This design, in conjunction with the contributing factors mentioned above, may impact the rate at which torque is transferred from the terminal pin to the helix mechanism.Approved instructions for use provide best practices to mitigate these potential contributing factors.

Event Description

Boston scientific received information that this right atrial (ra) lead was not successfully implanted due to helix issues.As a result of the helix issues the procedure time was extended and the patient required narcan to reverse sedation.No additional adverse patient effects were reported.

• 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: 6701182
• MDR Text Key: 79628717
• Report Number: 2124215-2017-09697
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526523458
• UDI-Public: (01)00802526523458(17)20190426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2019
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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; 7742; L311
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR