MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number A-TCSE-DF

Device Problem Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2022

Event Type  malfunction  

Event Description

Radiofrequency catheter would not work, generator kept reading high impedance.Once catheter was replaced with a new one, no issues.

• Brand Name: TACTICATH¿
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; saint paul MN 55117
• MDR Report Key: 14841882
• MDR Text Key: 294855506
• Report Number: 14841882
• Device Sequence Number: 1
• Product Code: OAE
• 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: 06/15/2022

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 Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6570 DA
• Patient Sex: Female