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

Model Number STSF DF

Device Problem Failure to Sense (1559)

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

Event Date 09/09/2019

Event Type  malfunction  

Event Description

When the mapping catheter was plugged into the mapping system, it wouldn't register with the system.We replaced the cable connection and that didn't work so we replaced the mapping catheter and that worked.

Event Description

When the mapping catheter was plugged into the mapping system, it wouldn't register with the system.We replaced the cable connection and that didn't work so we replaced the mapping catheter and that worked.

• Brand Name: THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 9161337
• MDR Text Key: 161382842
• Report Number: 9161337
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: STSF DF
• Device Catalogue Number: D134805
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22265 DA