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	04/27/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that a male patient with a date of birth of (b)(6) 1946 underwent a persistent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator (us) and the patient suffered an esophageal fistula requiring surgical intervention and ultimately resulting in death.It was reported that an esophageal fistula was discovered a month after a persistent a-fib case which occurred on 24-mar-2022.The patient was experiencing chills and discomfort about a month after the procedure and went to the emergency room.An esophageal fistula was confirmed by ultrasound imaging but that they are unsure of the type of ultrasound imaging used.They attempted to stent the esophageal fistula as intervention, but the patient passed away 2-3 days following the stent procedure.The physician was unsure of the reason for the injury or death.After the biosense webster inc representative reviewed the case with the physician, it was the physician¿s opination that everything was within parameters and there were no operator errors or increased force errors during the procedure.This adverse event was discovered post use of biosense webster products, a month later.The physician does not believe anything was done incorrectly or that any products were at fault, so the cause of the adverse event might have been a ¿patient condition¿ issue.The patient was in hospital for 3 days between discovery of issue and death; the date of death is (b)(6) 2022.There were no relevant tests, lab data, or history.A smartablate generator (sn (b)(4)) was used during the persistent a-fib ablation case.Smartablate generator parameters were power control mode, 40w, temp cut-off 40.The correct catheter settings were selected on the smartablate generator, however, since the esophageal fistula was not discovered until a month later, temperature, impedance and power at the time of the perforation is unknown.An esophageal temperature probe was used during the ablation case for monitoring and to prevent esophageal injury.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.The carto® 3 system did not indicate to re-zero the catheter.Dashboard, vector, and visitag force visualization features were used.The visitag module parameters for stability used were range: 3mm, time: 3sec, force over time of 3g at 25%, respiratory gated.No additional filter was used with the visitag.Surpoint posterior wall target ~380 and color options were used prospectively.
Additional Manufacturer Narrative
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: manufacture report number # 2029046-2022-01064 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter); importer report number product code m490007 (smartablate¿ system rf generator (us)).
Additional Manufacturer Narrative
On 26-may-2022, additional information was received indicating the date of event was actually 27-apr-2022.As such, field b3.Date of event has been updated accordingly.Biosense webster inc.'s reference number (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (US)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 14442424
• Report Number: 2029046-2022-50007
• Device Sequence Number: 4435980
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022
• Report Date (Section F): 05/04/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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.; ESOPHAGEAL TEMPERATURE PROBE.; SMARTABLATE PUMP KIT-US.; THMCL SMTCH SF BID, TC, D-F.
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 97 KG