MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

During attempted implant of the left ventricular (lv) lead, the lv lead with serial number (b)(4) dislodged during slitting.The lv lead was removed and a different lv lead with serial number (b)(4) was used.During attempted implant of the lv lead with serial number (b)(4), the suture sleeve moved down the lv lead and during attempted retrieval, the patient had bleeding.The suture sleeve was left in place and a new suture sleeve was used.There was difficulty removing the stylet from the lead body.During attempted removal of the stylet, the lv lead broke.The lv lead was removed and the procedure was rescheduled.The patient was in stable condition following the surgery and there were no adverse consequences.Related manufacturer's reference number: 2017865-2022-04476.

Manufacturer Narrative

The reported events were suture sleeve movement, difficulty removing the stylet from the lead body, and lead damage.As received, a complete lead was returned in two pieces with the stylet stuck inside the connector portion of the lead and a suture sleeve.The reported events of difficulty removing the stylet from the lead body, and lead damage were confirmed.The cause of the reported event of lead damage was isolated to procedural damage.The cause of the reported event of difficulty removing the stylet from the lead body was isolated to the bunching of stripped stylet ptfe coating and inner coil.Visual inspection of the suture sleeve did not find any anomalies.The inner diameter of the suture sleeve and inner diameter to the groove were measured to be within specification.

• 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: 13654525
• MDR Text Key: 286560939
• Report Number: 2017865-2022-04479
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 04/05/2022

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: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000084462
• 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: 02/15/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1