MAUDE Adverse Event Report: ABBOTT QUARTET; NO MATCH

Model Number 1458Q/86

Device Problems Separation Failure (2547); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

During the initial implant procedure, the physician experienced difficulty removing the stylet from the left ventricular (lv) lead.While attempting to remove the stylet, the connector pin came loose from the body of the lead.The lv lead was explanted and replaced to complete the implant procedure.The patient was in stable condition.

Manufacturer Narrative

The reported events of difficulty removing the stylet and lead damage were confirmed.As received, a partial proximal portion of the lead with stuck stylet was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.The polytetrafluoroethylene (ptfe) coating of the stuck stylet was stripped and was found bunched up with the inner coil distal to the connector pin.The connector pin with the crimp sleeve were found pulled out of the connector assembly stretching the inner coil consistent with damage due to excessive forces applied while attempting to remove the stylet from the lead during the procedure.The cause of the reported events of difficulty removing the stylet and lead damage was isolated to the bunching of the stylet ptfe coating inside the inner coil at the connector region that prevented the removal of the stylet and excessive forces resulted in the connector pin to be pulled out through the connector assembly.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18248193
• MDR Text Key: 329501523
• Report Number: 2017865-2023-93651
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000144410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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