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

Model Number D134804

Device Problem No Display/Image (1183)

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

Event Date 04/09/2019

Event Type  malfunction  

Event Description

Ablation catheter was not showing temperature on monitor.The device was unplugged and retried, but it did not work.So another device was used (same type) and worked fine.

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 33 technology dr; irvine CA 92618
• MDR Report Key: 8559943
• MDR Text Key: 143407259
• Report Number: 8559943
• 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: 04/15/2019,04/11/2019

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: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30162598L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1