MAUDE Adverse Event Report: ABBOTT 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 07/06/2023

Event Type  malfunction  

Event Description

During an implant procedure, the left ventricular (lv) was unable to separate from the guidewire resulting in lead insulation damage.The lv lead was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events of stylet could not be removed and insulation damage were confirmed.As received, a complete lead was returned in one piece with the stylet stuck inside the lead.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 and the ptfe stylet coating was bunched up/clogged with the inner coil distal to the connector pin.The cause of the reported event was due to bunched up ptfe coating of the stylet inside the inner coil that prevented the removal of the stylet and excessive forces resulted in the connector pin and crimp sleeve to be pulled out of the connector assembly.Further analysis found procedural damage to the lead insulation distal to the connector boot.The cause of the reported event of insulation damage was isolated to procedural damage.

• Brand Name: QUARTET
• 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: 17392756
• MDR Text Key: 319788735
• Report Number: 2017865-2023-36700
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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: 09/11/2023

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: S000090630
• 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: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• 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