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

Model Number	D132704
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: the temperature sensor on the catheter tip malfunctioned.It malfunctioned more than halfway through the ablation procedure.The doctor could not see the temperature during the ablation.Md had to get a new ablation catheter.From the procedural note: radiofrequency ablation was performed with the f/j biosense-webster smarttouch ablation catheter.Initially, ablation was performed retrogradely through the aorta, and the catheter was repositioned in the antrum and aortic mitral continuity.With the ablation in this location, the patient had suppression of ventricular ectopy, but was not completely eliminated.Ablation was guided by pace mapping and activation mapping.Therefore, the ablation catheter was then positioned transseptal into the anterior mitral annulus and ablation in this location eliminating ventricular ectopy.After 20 minutes of observation, the patient did not have any ventricular ectopy.There were no complications.

• Brand Name: THERMOCOOL SMARTTOUCH
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 10683038
• Report Number: 10683038
• Device Sequence Number: 11472235
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: (01)10846835009194(17)210614(10)30387231M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/13/2020
• Report Date (Section F): 10/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30387231M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 131
• Date Report Sent to FDA: 10/13/2020