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

Model Number D134804

Device Problem Failure to Deliver Energy (1211)

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

Event Date 03/18/2019

Event Type  malfunction  

Event Description

Radiofrequency (rf) catheter was placed into the left atrium for rf application.Once generator was turned on, there was no temperature indicated, and did not allow delivery of energy.Generator was turned off and restarted, still no improvement.Ablation cable was replaced with a non-reprocessed cable, still no improvement and the catheter still did not register.Replaced catheter with a new rf stsf fj curve catheter.Temperature and impedance were recognized by the generator and rf application was applied.Procedure continued successfully.No harm.

Event Description

Radiofrequency (rf) catheter was placed into the left atrium for rf application.Once generator was turned on there was no temperature indicated, and did not allow delivery of energy.Generator was turned off and restarted, still no improvement.Ablation cable was replaced with a non-reprocessed cable, still no improvement and the catheter still did not register.Replaced catheter with a new rf stsf fj curve catheter.Temperature and impedance were recognized by the generator and rf application was applied.Procedure continued successfully.No harm.

• 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: 8495057
• MDR Text Key: 141317160
• Report Number: 8495057
• 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: 04/04/2019

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16425 DA