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 01/16/2024

Event Type  Death  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation, and the patient experienced an esophageal fistula that resulted in death.It was reported that an esophageal fistula was received from an emergency room (er) physician on a patient who had gone through an afib procedure on (b)(6) 2024.The physician stated that the patient came to the er on that date complaining of chest discomfort.The patient was sent for a computed tomography (ct) scan to evaluate the issue and passed away while having the ct scan done.There was no information regarding the ablation or diagnostic catheters nor has the information for the generator used for ablation.Additional information received indicated that the lot numbers of the devices are unknown as the event did not occur until weeks after the ablation.Therefore, all catheters and cables had been sent to reprocessing.Confirmation was received that a smartablate generator was used and the serial number was provided.The physician¿s opinion on the cause of death was atrio-esophageal (ae) fistula.It is unknown when in the procedure the fistula occurred as the physician and staff were very diligent and conservative when monitoring esophageal temperature during ablation of posterior wall.There was no device malfunction reported on bwi products.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.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: (1) manufacture report number # 2029046-2024-00790 for product code unk (thermocool® smart touch® sf uni-directional navigation catheter).(2) uf/importer report number # 2029046-2024-50002 product code m490007 (smartablate¿ system rf generator (us)).

• 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: 18877249
• MDR Text Key: 337354256
• Report Number: 2029046-2024-50002
• 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: 02/20/2024,03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 02/14/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2017
• 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 UNIDIRECTIONAL SF
• Patient Outcome(s): Death; Life Threatening