MAUDE Adverse Event Report: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION SAFIRE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 402806

Device Problem Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

St jude safire catheter #402806, lot# 7693429.Could not ablate due to impedance spike.Catheter was removed and case was completed using a different catheter (medtronic cryocath).Manufacturer response for ablation catheter, safire catheter (per site reporter) clinical site corresponded with the manufacturer rep directly.

• Brand Name: SAFIRE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL CARDIOVASCULAR DIVISION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 14943991
• MDR Text Key: 295415554
• Report Number: 14943991
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402806
• Device Catalogue Number: 402806
• Device Lot Number: 7693429
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other