MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL FLOW DIRECTED PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 401763

Device Problem Pacing Problem (1439)

Patient Problems Arrhythmia (1721); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/28/2023

Event Type  Injury  

Event Description

During a transcatheter aortic valve replacement procedure when the valve was deployed, a premature ventricular contraction occurred.During the procedure, the temporary pacing catheter failed to capture, causing the valve to deploy approximately 2-3 mm distal to the intended site.A transthoracic echocardiogram and cineangiography were performed which revealed a perivalvular leak.It was felt that failure of the temporary pacing catheter to maintain capture led to the complication / inappropriate placement of valve.Fda ref: mw5115460.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported valvular insufficiency remains unknown.

• Brand Name: PACEL FLOW DIRECTED PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16590456
• MDR Text Key: 311755521
• Report Number: 2182269-2023-00014
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: 05414734007856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 401763
• Device Catalogue Number: 401763
• Device Lot Number: 8594836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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
• Patient Age: 81 YR