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

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2020

Event Type  malfunction  

Event Description

Char formation on biosense webster st-sf ablation catheter during vt ablation procedure.No adverse event to pt during procedure.Fda safety report id# 497120.See scanned pages.

• Brand Name: BIOSENSE WEBSTER SMARTTOUCH SF ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. ; diamond bar CA
• MDR Report Key: 9711703
• MDR Text Key: 179958634
• Report Number: MW5093011
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other