MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE¿ SYSTEM RF GENERATOR (US); CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	M490007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number (b)(4) has two reports: manufacture report number # 2029046-2022-00613 for product code unk_smart touch bidirectional sf (thermocool® smart touch® sf bi-directional navigation catheter) importer report number # 2029046-2022-50005 product code m490007 (smartablate¿ system rf generator (us)).
Event or Problem Description
It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient suffered an esophageal fistula requiring surgical intervention.The patient went to the hospital on (b)(6) 2022 due to a complication with from the atrial fibrillation (afib) ablation procedure completed on (b)(6) 2022.The patient returned with an esophageal fistula for a treatment.The esophageal injury was confirmed on (b)(6)2022.The physician¿s opinion on the cause of this adverse event is that it was procedure related.Emergency cardiothoracic surgery was required.The patient outcome of the adverse event is unknown, however, the patient required extended hospitalization because of the adverse event and was still hospitalized in an unknown condition.A smartablate¿ system rf generator (us) was used in the atrial fibrillation (afib) ablation procedure.It was used in power control mode at 50w with the correct catheter setting selected.The smartablate pump was switching from low to high flow during ablation no error messages observed on biosense webster equipment during the procedure.An esophageal temperature probe was monitored by anesthesia.Force visualization features used were dashboard, vector, visitag with tag index.

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (US)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 13873885
• Report Number: 2029046-2022-50005
• Device Sequence Number: 20149587
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2022
• Report Date (Section F): 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M490007
• Device Catalogue Number: M490007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2022
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; ESOPHAGEAL TEMPERATURE PROBE; SMARTABLATE PUMP KIT-US; UNK_SMART TOUCH BIDIRECTIONAL SF
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown