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

Model Number 1458Q/86

Device Problems Break (1069); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2023

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, the left ventricular (lv) lead failed to be separated from the guidewire.Upon multiple attempts to remove the guidewire, the connector pin got detached from the lead.The lv lead was then removed.No patient condition was reported.

Event Description

New information received indicated that post-ablation procedure, it was noticed on the date of the implant procedure that when using intracardiac echo to access the coronary sinus the patient had experienced thrombosis.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The reported event of stylet could not be removed and ¿the connector pin got detached from the lead¿ was confirmed.As received, a partial lead with a stuck stylet was returned in one piece.The polytetrafluoroethylene ptfe coating of the stuck stylet was stripped and was found bunched up with the inner coil distal to the connector pin.The connector pin with the crimp sleeve was found pulled out stretching the inner coil, consistent with damage due to excessive forces applied while attempting to remove the stylet from the lead during the procedure.The connector cap was missing/not returned with the lead.The cause of the reported event was isolated to bunched up ptfe coating of the stylet that prevented the removal of the stylet and excessive forces resulted in the connector pin and crimp sleeve being pulled out of the connector assembly.

• 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: 17883365
• MDR Text Key: 325075295
• Report Number: 2017865-2023-47914
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: A000124598
• 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: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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