MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Difficult to Insert (1316); Product Quality Problem (1506); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During an implant procedure, there was difficulty inserting and advancing the left ventricular (lv) lead into the introducer.The suspected cause of the insertion and advancement difficulty was a manufacturing anomaly.A different lv lead was implanted to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events were an insertion issue and a manufacturing issue.As received, a complete lead was returned for analysis.The associated sub-selector catheter was not returned with the lead.The reported event of an insertion issue was not confirmed.The s-curve hump height was unable to be measured, due to the damaged lead.The ring electrodes were measured, and all were within product specification.An insertion test was performed using a sample cps catheter and guidewire.Despite the damage found at the s-curve region, the lead was able to be fully inserted and removed successfully with no resistance.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11753757
• MDR Text Key: 248232664
• Report Number: 2017865-2021-16925
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000080265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 05/03/2021; 06/30/2021
• Supplement Dates FDA Received: 05/04/2021; 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1