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

Model Number 1456Q/86

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

During initial implant procedure, it was not possible to advance or remove the guidewire from the left ventricular (lv) lead.The lead was explanted and replaced to resolve the event.The patient was stable and there were no consequences.

Manufacturer Narrative

The reported events of unable to advance and remove guidewire was confirmed.As received, a complete lead with a stuck guidewire was returned in one piece for analysis.The inner coil inside the connector region was found bunched up.The polytetrafluoroethylene (ptfe) coating of the guidewire was stripped and found inside the connector pin.The cause of the reported event was due to bunching of inner coil and ptfe coating of the guidewire distal to connector pin.

• 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: 17908775
• MDR Text Key: 325338573
• Report Number: 2017865-2023-48224
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 11/09/2023

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 Model Number: 1456Q/86
• Device Lot Number: A000142011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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