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

Model Number D132704

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  malfunction  

Event 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
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 10683038
• MDR Text Key: 211478710
• Report Number: 10683038
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: (01)10846835009194(17)210614(10)30387231M
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30387231M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 131