MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. THERMOCOOL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134850

Device Problem Flushing Problem (1252)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

Flushed device to connect to system and it "wouldn't work".Cables were checked, device unplugged and re-plugged, rebooted system with hard re-boot.

• Brand Name: THERMOCOOL
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 15939718
• MDR Text Key: 305075817
• Report Number: 15939718
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022,11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: D134850
• Device Lot Number: NOT AVAIL
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1