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	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent a atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient suffered an esophageal fistula and required surgical intervention.It was reported by the caller, the biosense webster inc.(bwi) representative, that there was an issue after a case that may had happen at the beginning of (b)(6) 2022.The caller stated not to know the exact date of the procedure and provided best estimate date of (b)(6) 2022.The physician in a casual conversation with the caller mention a fistula that was discovered on a visit to the emergency room after the patient reported having trouble swallowing while eating.The caller stated that the patient has then been treated and had gone through surgery and recovery.The caller stated that the physician mentioned the patient had esophageal issues prior to the procedure.The caller also stated that he works with the physician on a daily basis and knows the flow of the physician.Additional information was later received indicating the adverse event was discovered post use.Patient required surgery to address the esophageal fistula.Patient was reported to be fully recovered.Temperature control mode was used and set to 40 watts.The esophagus was mapped and they used a temperature probe to monitor the temperature during the procedure.The smartablate generator and pump was set properly and functioning properly.No re-zero prompt was observed.Force visualization features utilized were dashboard, vector and visitag.Visitag module was used, what parameters for stability were used standard 3g,3sec,25%,2.5mm.Color option was surpoint.
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 # 2029046-2023-00139 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter), product code m490007 (smartablate¿ system rf generator (us)).
Additional Manufacturer Narrative
On 26-jan-2023, the serial number of the smartablate generator was provided as g4c-2406.As such, field d4.Serial has been populated with this information.Additionally, from this information, we have also determined the age of the device to be 4 years.Fields f9.Approximate age of device and f9.Age of device unit have been appropriately populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a female patient underwent a atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient suffered an esophageal fistula and required surgical intervention.It was reported by the caller, the biosense webster inc.(bwi) representative, that there was an issue after a case that may had happen at the beginning of (b)(6) 2022.The caller stated not to know the exact date of the procedure and provided best estimate date of (b)(6) 2022.The physician in a casual conversation with the caller mention a fistula that was discovered on a visit to the emergency room after the patient reported having trouble swallowing while eating.The caller stated that the patient has then been treated and had gone through surgery and recovery.The caller stated that the physician mentioned the patient had esophageal issues prior to the procedure.The caller also stated that he works with the physician on a daily basis and knows the flow of the physician.Device investigation details: the device investigation has been completed which included performing a device history record (dhr) review.The device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.A service work order for the smartablate¿ system rf generator (us) was not received.As such, no further analysis could be performed and no additional information was obtained at this time.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Importer's ref.# (b)(4).

• 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: 16219205
• Report Number: 2029046-2023-50001
• Device Sequence Number: 5991774
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 09/26/2023
• Report Date (Section F): 01/20/2023

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/22/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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.; THMCL SMTCH SF BID, TC, F-J.; UNKNOWN PUMP.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown