MAUDE Adverse Event Report: ABBOTT QUARTET; NO MATCH

Model Number 1458Q/86

Device Problem Break (1069)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

It was reported that prior to the procedure, the left ventricular (lv) lead's insulation was pierced by the guidewire.The lead was not used and a new lv lead was implanted to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of insulation damage was confirmed.As received, a complete lead was returned in one piece.A visual examination revealed the lead body insulation was perforated.An x-ray examination revealed the inner coil was offset at the s-curve region consistent with procedural damage.The cause of the reported event is consistent with procedural damage.Additionally, electrical testing revealed no 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: 18155248
• MDR Text Key: 328332433
• Report Number: 2017865-2023-52709
• 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: 01/02/2024

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: 1458Q/86
• Device Lot Number: S000091476
• 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: 10/30/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2023
• 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