MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458QL/86

Device Problems Break (1069); Failure to Advance (2524); Separation Failure (2547)

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

Event Date 07/13/2022

Event Type  malfunction  

Event Description

It was reported a stylet was unable to be inserted into the left ventricular (lv) lead during the implant procedure.Another stylet was inserted into the lead, but it was unable to be removed from the lv lead.As a result the proximal end of the lead was damaged.The lv lead was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported events of inability to insert a stylet, failure to remove a stylet and lead damage were confirmed.As received, a complete lead with a partial stylet stuck was returned in one piece.The polytetrafluoroethylene (ptfe) coating of the stuck stylet was stripped and was found to be bunched up with the inner coil distal to the connector pin.The connector pin with the cap and crimp sleeve were revealed to be pulled out of the molded connector 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 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 and cap to be pulled out through the connector assembly.A review of the device history record (dhr) confirmed that no issues were identified related to this reported event.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15113267
• MDR Text Key: 304026881
• Report Number: 2017865-2022-16199
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• 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: 09/21/2022

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: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000125453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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