MAUDE Adverse Event Report: ABBOTT QUARTET LEAD SMALL-S, 86 CM; NO MATCH

Model Number 1456Q/86

Device Problems Fracture (1260); Separation Failure (2547)

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

Event Date 12/21/2023

Event Type  malfunction  

Event Description

During the initial implant procedure, the stylet was unable to be removed from the left ventricular (lv) lead.While attempting to remove the stylet, the stylet fractured.The lv lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported events of stuck stylet and fractured stylet were confirmed.As received, a complete lead with stuck stylet was returned in one piece.The stylet knob was separated from the stylet and was missing/not returned, and the polytetrafluoroethylene (ptfe) coating was stripped and was found bunched up with the inner coil distal to the connector pin consistent with procedural damage.The connector pin with the crimp sleeve were found pulled out of the connector assembly slightly 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 was isolated to the bunching of the stylet ptfe coating inside the inner coil at the proximal region that prevented the removal of the stylet and excessive forces resulted in the connector pin with the crimp sleeve to be pulled out through the connector assembly and broken/fractured stylet.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• 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: 18489151
• MDR Text Key: 332601133
• Report Number: 2017865-2024-00904
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1456Q/86
• Device Lot Number: A000144658
• 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: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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