MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the implant procedure, the guidewire could not be inserted into the left ventricular (lv) lead.The lv lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

As received, a complete lead was returned in one piece.The guidewire was inserted through the proximal end of the lead all the way through with no restrictions noted.Visual inspection of the lead did not find any anomalies with the exception of procedural damage.The reported event of guidewire could not be inserted was not confirmed.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10139141
• MDR Text Key: 194668782
• Report Number: 2017865-2020-07379
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

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 Expiration Date: 08/31/2022
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000073006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1