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

Model Number	M490007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	07/11/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 # 2029046-2022-02395 for product code unk_smart touch bidirectional (thermocool® smart touch¿ bi-directional navigation catheter) (b)(4).
Event or Problem Description
It was reported that a female 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 suffered an esophageal fistula after the procedure which resulted in the patient¿s death.It was reported that when the bwi representative walked into the account, they were notified that a patient they did a posterior wall isolation procedure on (b)(6) 2022, died approximately a week later at another hospital.The bwi representative was not there at the initial procedure and has no information about the procedure.The bwi representative was informed on (b)(6) 2022, about this event which happened at least 6-7 weeks earlier.From what the bwi representative understood, the patient had an esophageal fistula that caused her death.No additional patient, product or procedure details are 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: 15541166
• Report Number: 2029046-2022-50010
• Device Sequence Number: 6107716
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/04/2022
• Report Date (Section F): 09/12/2022

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; SMARTABLATE PUMP KIT-US; UNK_SMART TOUCH BIDIRECTIONAL
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown