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

Model Number D134702

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2020

Event Type  malfunction  

Event Description

Ablation catheter sensor had an error; unable to use catheter; vendor called in to replace catheter.

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd; baldwin park CA 91706
• MDR Report Key: 11684664
• MDR Text Key: 246012777
• Report Number: 11684664
• 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: 04/09/2021,01/07/2021

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: No Information
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30376786M
• 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: 04/09/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA