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

Model Number 1458Q/86

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

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

Event Date 07/14/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for scheduled generator upgrade procedure.During the procedure, while positioning the left ventricular lead, the catheter was becoming stuck on the lead and had to be flushed with lubricant.While attempting to slit the catheter, the lead was dislodged.The lead was kinked and could not be re-positioned.The lead was not used, and a new lead was implanted.The patient condition was stable.

Manufacturer Narrative

The reported events were lead dislodgement, ¿lead becoming stuck on the catheter¿, and ¿lead kinked¿.As received, a complete lead was returned in one piece for analysis.The reported event of ¿lead kinked¿ was confirmed.Visual inspection found the lead insulation punctured/damaged at the proximal region of the lead consistent with procedural damage.The reported event of ¿lead becoming stuck on the catheter¿ could not be confirmed.The guide wire could not be inserted into the lead due to the condition of the inner coil as received.

• 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: 17390570
• MDR Text Key: 320112069
• Report Number: 2017865-2023-36663
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• 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: A000140016
• 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: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• 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 ASSURA; RIGHT VENTRICULAR LEAD; TENDRIL
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 91 KG