MAUDE Adverse Event Report: ST. JUDE MEDICAL CARDIOLOGY DIVISION, INC. PACEL 5F FLOW DIRECTED PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number 401763

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

Clear fluid backing up into transvenous pacer sleeve.5f flow directed pacing catheter.I do not have the lot number and the product was disposed of in the ep lab when patient went for a permeant pacer.There was zero harm reached to patient and i just wanted to document an rl in case we have an issue again with this product.

• Brand Name: PACEL 5F FLOW DIRECTED PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL CARDIOLOGY DIVISION, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 18064596
• MDR Text Key: 327270684
• Report Number: 18064596
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2023

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 Catalogue Number: 401763
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1