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

Model Number 1458Q/86

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

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

Event Date 01/04/2024

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 had failed to be separated from the left ventricular (lv) lead and an attempt to separate the stylet from the lead had resulted in the inner cable of the lv lead to come out.The lead was not used, and a new lead was implanted.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported events of stylet could not be removed and ¿inner cable came back with the stylet¿ were confirmed.As received, a complete lead was returned with the stylet stuck inside both portions.Visual inspection of the lead found that the connector pin and crimp sleeve were pulled out of the connector assembly along with the inner coil which is consistent with procedural damage.Additionally, the ptfe stylet coating was bunched up/clogged with the inner coil distal to the connector pin which prevented the removal of the stylet.Excessive forces had resulted in the connector pin and 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: 18561811
• MDR Text Key: 333445016
• Report Number: 2017865-2024-01649
• 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: 02/06/2024

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 Model Number: 1458Q/86
• Device Lot Number: A000149095
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2023
• 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: QUADRA ALLURE; RIGHT ATRIAL LEAD; RIGHT VENTRICULAR LEAD
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White