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	02/01/2020
Type of Reportable Event	Serious Injury
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.Note: the exact date of the adverse event could not be confirmed, it was reported the event occurred in (b)(6) of 2020, as such.Date of event has been defaulted to (b)(6) 2020.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 # 2029046-2022-01599 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).Importer report number # 2029046-2022-50008 product code m490007 (smartablate¿ system rf generator (us)).
Event or Problem Description
It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure in (b)(6) 2020 with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient suffered an esophageal fistula requiring surgical intervention and prolonged hospitalization.After an atrial fibrillation case completed, within a week or two of the case, an atrio-esophageal fistula was noticed in the patient.The patient got on an airplane against the advice from the doctor and then felt unwell or "crummy." the patient was admitted to the emergency room (er) and then the patient was admitted into surgery.The bwi representative did not have any other event details available at the time of the call.The patient was reported to be in stable condition.The physician¿s opinion is that it had nothing to do with the product.It was just an unfortunate event as no signs indicated us to a fistula occurring i.E.Esophageal temperature was constantly monitored and did not rise more than 0.5 degrees c before physician would move to a different location.The patient did require extended hospitalization because of the adverse event.The bwi sales consultant does not know the full specifics.Esophageal temperature monitoring was used to prevent esophageal injury.

• 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: 15008865
• Report Number: 2029046-2022-50008
• Device Sequence Number: 19431959
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/13/2022
• Report Date (Section F): 06/22/2022

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: 06/17/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: THMCL SMTCH SF BID, TC, F-J
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male