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

Model Number 1458Q/92

Device Problems Break (1069); Separation Failure (2547)

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented for a lead revision procedure.During the procedure, it was noted that the stylet was failing to be removed from the left ventricular (lv) lead.The lv lead was damaged when attempting to remove the stylet.The lv lead was not used.The physician elected to use another lv lead and completed the procedure.The patient was in stable condition.

Manufacturer Narrative

The reported event of stylet stuck and ¿the lead broke while attempting to pull stylet out¿ were confirmed.A complete lead with stuck stylet was returned in one piece.The 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 were found pulled out of the connector assembly 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 intact and in place in the connector assembly.The cause of the reported events 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 and excessive forces resulted in the connector pin with the crimp sleeve to be 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: 18957077
• MDR Text Key: 338304583
• Report Number: 2017865-2024-35636
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/92
• Device Lot Number: A000145297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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
• Treatment: DURATA TACHY MRI LEAD; GALLANT HF ICD; MRI COND. TENDRIL LEAD
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 70 KG