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

Model Number D134703

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/06/2019

Event Type  malfunction  

Event Description

Ablation catheter was defective in afib ablation with doctor.Catheter was removed from patient and field.Packaged to be sent back and defective paperwork filled out.

• 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: 16815460
• MDR Text Key: 314014177
• Report Number: 16815460
• 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: 04/19/2023,08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: D134703
• Device Catalogue Number: D134703
• Device Lot Number: 30202427L
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1