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

Model Number D134802

Device Problems Difficult to Remove (1528); Device Displays Incorrect Message (2591)

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

Event Date 04/10/2020

Event Type  malfunction  

Event Description

Ablation catheter failed after using for 45 min, giving a temp reading error of 26 (well below the limit) and when we tried to step on ablation, again it would give a reading of 21 degree temp and would not allow us to ablate.

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 10249941
• MDR Text Key: 198093421
• Report Number: 10249941
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: D134802
• Device Catalogue Number: D134802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2020
• Event Location: Other
• Date Report to Manufacturer: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA