MAUDE Adverse Event Report: ABBOTT QUARTET; NO MATCH

Model Number 1458Q/86

Device Problem Failure to Advance (2524)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

During an implant procedure, the guidewire was unable to be advanced into the left ventricular (lv) lead.The lv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported event of failure to advance the guide wire was confirmed.As received a complete lead was returned in one piece for analysis.Visual examination and the guidewire test found the inner coil clogged with foreign material consistent with material most likely occurring during time of procedure.The cause of the reported event was isolated to the foreign material blocking the inner coil.

• 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: 18188688
• MDR Text Key: 328747548
• Report Number: 2017865-2023-72955
• 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: 01/25/2024

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: S000090705
• 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: 11/08/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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