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

Model Number	M490007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 # 2029046-2023-01043 for product code d134702 (thermocool® smart touch® sf uni-directional navigation catheter); (2) importer report number # 2029046-2023-50011 product code m490007 (smartablate¿ system rf generator (us)).
Event or Problem Description
It was reported that a patient underwent an afib - paroxysmal ablation procedure with an thermocool® smart touch® sf uni-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient developed an esophageal fistula post-procedure requiring surgical intervention and prolonged hospitalization.It was reported that an esophageal fistula occurred post-procedure.They reported that the procedure occurred on (b)(6) 2023 but they were unable to confirm the date that the esophageal fistula was discovered.The caller reported that they were notified of the esophageal fistula on (b)(6) 2023.They were unable to confirm how the esophageal fistula was discovered and confirmed.They were unable to confirm what medical intervention was provided.The patient was in stable condition.There were no issues during the procedure.There were no patient consequences on the day of the procedure and that the patient left in "great condition".The physician¿s opinion on the cause of this adverse event is that it was procedure related.Intervention provided was surgery and the patient¿s outcome from the adverse event was reported as improved.The patient required extended hospitalization because of the adverse event due to the surgery.Relevant tests included a computed tomography (ct).

• 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: 16943364
• Report Number: 2029046-2023-50011
• Device Sequence Number: 19668018
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 05/16/2023
• Report Date (Section F): 04/20/2023

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
• 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: 04/18/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2023
• 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: THMCL SMTCH SF UNID, TC, F
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 118 KG