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

Catalog Number M490007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 09/09/2021

Event Type  Death  

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 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)
• Type of Device: 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
• MDR Text Key: 328477720
• Report Number: 2029046-2023-50017
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2023,11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK_SMART TOUCH BIDIRECTIONAL
• Patient Outcome(s): Death