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

Catalog Number A-TCSE-FJ

Device Problems Unstable (1667); Device Sensing Problem (2917); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

Device prepped and flushed and plugged into system.Force sense inaccurate/unstable reported.Device was re-prepped and plugged back in but still would not work.

• Brand Name: TACTICATH
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11964854
• MDR Text Key: 255070897
• Report Number: 11964854
• 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: 05/26/2021,05/20/2021

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: Other
• Device Catalogue Number: A-TCSE-FJ
• Device Lot Number: 7774652
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1