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	12/07/2021
Type of Reportable Event	Serious Injury
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 # 2029046-2022-00298 for product code unk_smart touch bidirectional (thermocool® smart touch¿ bi-directional navigation catheter); importer report number # product code m490007 (smartablate¿ system rf generator (us).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) the patient suffered an esophageal fistula and was hospitalized.After an atrial fibrillation case had completed, an esophageal fistula was noticed in the patient.The patient was admitted to the emergency room (er), but it was unknown specifically what day they were admitted.The patient was intubated as of the time of the initial call.There is no further information about intervention that was performed.The caller reported that it was unknown if the patient is in stable condition.
Additional Manufacturer Narrative
On (b)(6) 2022, biosense webster inc.Received additional information about the patient and event.It was reported the patient was a female born on (b)(6)1954.The event was discovered post use of bwi products.The bwi representative heard about the event second hand from another physician.They have been unable to speak with the physician therefore the physician¿s opinion on the cause of this event is unknown.Further details about intervention and patient outcome are unknown as well.The physician¿s contact information was also provided and populated into section e.Initial reporter.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Importer ref.# (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: 13530344
• Report Number: 2029046-2022-50004
• Device Sequence Number: 17412044
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/11/2022
• Report Date (Section F): 01/19/2022

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: 02/14/2022
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/11/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR KIT-US.; UNK_SMART TOUCH BIDIRECTIONAL SF.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Female