MAUDE Adverse Event Report: ABBOTT QUARTET LEAD SMALL-S, 86 CM; NO MATCH

Model Number 1456Q/86

Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that the left ventricular (lv) lead was difficult to insert into the catheter during the implant procedure.Additionally, during the slitting process, the insulation of the lead was damaged.The lead was explanted and replaced and the patient was in stable condition.

Manufacturer Narrative

As received, a complete lead was returned in one piece.A visual inspection revealed cuts and damage to the lead body insulation at the middle region consistent with procedural damage.The cause of the slitter has damaged the lv lead insulation is consistent with procedural damage.The reported event of difficult to push the lead forward in the sheath was not confirmed.The catheter used in the field was not returned with the lead for analysis.The catheter insertion test was performed, and the lead could be inserted inside the catheter and removed without difficulties.Furthermore, electrical testing revealed no indication of conductor fractures or internal shorts.S-curve height was measured to be within required performance specification.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18454374
• MDR Text Key: 332196617
• Report Number: 2017865-2024-00506
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1456Q/86
• Device Lot Number: A000143926
• 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: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• 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