MAUDE Adverse Event Report: ABBOTT LABORATORIES TACTICATH SENSOR ENABLES CONTACT FORCE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number OAT6802

Patient Problem Insufficient Information (4580)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

Ablation catheter would not connect to the system.Manufacturer response for ablation catheter, tacticath sensor enables contact force ablation catheter (per site reporter) unknown.

• Brand Name: TACTICATH SENSOR ENABLES CONTACT FORCE ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park rd; abbott park IL 60064
• MDR Report Key: 17423712
• MDR Text Key: 320032831
• Report Number: 17423712
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: OAT6802
• Device Lot Number: 8921075
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1