MAUDE Adverse Event Report: ABBOTT QUARTET; NO MATCH

Model Number 1458Q/86

Device Problem Separation Failure (2547)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

During attempted implant, it was reported that the guidewire could not be removed from the left ventricular (lv) lead.A different lv lead was successfully implanted to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported event of guidewire could not be removed was confirmed.As received, a complete lead was returned in one piece.Visual and x-ray examination showed that the inner coil at the connector region was offset/bunched up and the guidewire was found bent and was bunched up at the distal tip of the lead consistent with procedural damage.The cause of the reported event was due to the bent and bunched up guidewire at the distal tip consistent with procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.

• 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: 18870905
• MDR Text Key: 337289848
• Report Number: 2017865-2024-34463
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: S000092471
• 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: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• 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