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

Catalog Number	M490007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	09/09/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device investigation details: multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.A manufacturer record evaluation cannot be conducted because the no serial number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Note: date of death was not provided, as such, the best estimated date is the procedure date.B2.Date of death has been populated with this information.Biosense webster inc.'s reference number (b)(4) has two reports: (1) manufacture report number # 2029046-2023-02690 for product code unk_smart touch bidirectional (thermocool® smart touch¿ bi-directional navigation catheter) (2) importer report number # (b)(4) product code m490007 (smartablate¿ system rf generator (us)).
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation ablation procedure using a thermocool® smart touch¿ bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient experienced esophageal fistula and the patient ultimately passed away.A patient expired post-atrial fibrillation ablation procedure which was performed on (b)(6) 2021, after which they developed an esophageal fistula (believed to be the cause of death).No further details about when or how the fistula was diagnosed, or the date the patient expired.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (US)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 31; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 18166338
• Report Number: 2029046-2023-50017
• Device Sequence Number: 6541419
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2023
• Report Date (Section F): 11/02/2023

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 Catalogue Number: M490007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK_SMART TOUCH BIDIRECTIONAL
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown