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

Model Number 1458Q/92

Device Problem Failure to Advance (2524)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for a procedure.During the procedure, it was found that the stylet was failing to advance in the left ventricle (lv) lead.The lv lead was not used.The physician continued with another lv lead and completed the procedure.There were no patient consequences reported.

Manufacturer Narrative

The reported event of ¿stylet stuck in lead¿ was confirmed.A complete lead with stylet stuck was returned in one piece.The polytetrafluoroethylene (ptfe) coating of the stylet was stripped and was found bunched up with the inner coil at the connector region.The cause of the reported event was isolated to the bunching of the stylet ptfe coating inside the inner coil at the connector region that prevented the removal of the stylet consistent with damage cause during the procedure.

Manufacturer Narrative

Correction: the product was received.Therefore, the box "not returned to manufacturer" should not have been checked in h3.

• 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: 17562309
• MDR Text Key: 321317948
• Report Number: 2017865-2023-38547
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503358
• UDI-Public: 05414734503358
• 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,Followup
• Report Date: 08/28/2023

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 Expiration Date: 08/31/2023
• Device Model Number: 1458Q/92
• Device Lot Number: A000100758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 08/23/2023; 08/24/2023
• Supplement Dates FDA Received: 08/23/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2020
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White