MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/86

Device Problem Failure to Advance (2524)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2024-35181.It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the catheter failed to advance in the left ventricular lead (lv).The physician attempted to complete the procedure with another lv lead but it was also observed that the catheter failed to advance and eventually the procedure was abandoned.The physician decided to complete the procedure with a dual chamber implantable cardioverter defibrillator (icd) system and the patient was in stable condition throughout the procedure.

Manufacturer Narrative

The reported event of failure to advance in the catheter was not confirmed.As received, a complete lead was returned in one piece for analysis.Electrical tests did not find any indication of conductor fractures or internal shorts.A visual inspection revealed that the lead insulation was cut in the middle of the region which is consistent with procedural damage.The inner coil was found to be kinked at multiple locations and damaged.The guidewire was unable to be inserted due to the condition of the inner coil as received.The lead insertion test was performed and the catheter could be fully inserted without any difficulty.No other anomalies were seen.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18919473
• MDR Text Key: 337852665
• Report Number: 2017865-2024-35180
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: A000150449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female