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

Model Number 1458Q/86

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Fatigue (1849)

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the stylet could not be pulled out from the left ventricular (lv) lead.Eventually, the stylet was pulled out along with the lv lead and the lead was broke.The lead was replaced during the procedure to resolve the issue.The patient experienced fatigue during the procedure, but remained in a stable in condition afterwards.

Manufacturer Narrative

The reported events of stylet could not be removed and ¿proximal tip had broken¿ were confirmed.Final analysis found that as received, a partial lead (connector portion) was returned in one piece with the stylet stuck inside the lead.Visual inspection of the lead found that the connector pin and connector cap were pulled out of the connector assembly along with the inner coil which is consistent with procedural damage and the polytetrafluoroethylene (ptfe) stylet coating was bunched up/clogged with the inner coil distal to the connector pin.The cause of the reported events was due to bunched up ptfe coating of the stylet that prevented the removal of the stylet and excessive forces resulted in the connector pin and cap to be pulled out of the connector assembly.A device history record review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: 18140414
• MDR Text Key: 328172727
• Report Number: 2017865-2023-52509
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: IZ
• 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
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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: S000090715
• 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: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• 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