MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134703

Device Problem Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

The ablation catheter failed to operate as normal due to a sensor error in the catheter.

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 16852781
• MDR Text Key: 314379716
• Report Number: 16852781
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023,06/26/2020

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: D134703
• Device Catalogue Number: D134703
• Device Lot Number: 30317581M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male