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

Catalog Number UNK_SMARTABLATE GENERATOR

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

Patient Problem Fistula (1862)

Event Date 11/22/2023

Event Type  Death  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient experienced esophageal fistula that resulted in death.It was reported the patient was admitted to the emergency room and esophageal fistula was discovered.The patient expired from the injury.Unfortunately, there is no other information available at this time.It is unknown when the original procedure took place, as well as when the patient went to the emergency room and was admitted.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

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.Therefore, no product investigation can be performed, and the customer complaint cannot be confirmed.Since no serial number was provided, no manufacturer record evaluation could be performed.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: since no date of death was provided, the best estimate is considered to be (b)(6)2023.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number pc-001487977 has two reports: (1) manufacture report number # 2029046-2023-02981 for product code unk_smart touch bidirectional.(2) importer report number # 2029046-2023-50020 product code unk_smartablate generator.

• 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: 18337390
• MDR Text Key: 330618884
• Report Number: 2029046-2023-50020
• Device Sequence Number: 1
• Product Code: LPB
• 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: 11/23/2023,12/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMARTABLATE GENERATOR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; UNK_SMART TOUCH BIDIRECTIONAL.
• Patient Outcome(s): Death