MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

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 an implant procedure when attempting to place the left ventricular (lv) lead, the physician had difficulty operating the lead and noted the lead was stiffer than usual.Then, when attempting to cut the cps, the lead was cut instead due to the unusual stiffness of the lead.The lv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Additional information: d10, h3, and h6.The reported event of the lead getting in the way of the blade, causing the lead to come out of the coronary sinus, resulting in the lead being cut was confirmed.As received, a complete lead was returned in one piece for analysis.Electrical testing did not reveal any indication of conductor fractures or internal shorts.The s-curve hump height was revealed to be within product specification.Visual inspection of the lead revealed the lead insulation to be cut/sliced, which exposed the inner coil and ring electrode three, due to procedural damage.The cause of the reported event was isolated to procedural lead damage.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10832684
• MDR Text Key: 216091943
• Report Number: 2017865-2020-17686
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000078337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1