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

Catalog Number	M490007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: this event was originally reported under manufacturer report number 2029046-2024-00323 as the ngen generator.However, information received by bwi on 22-mar-2024 confirmed that the generator used in the procedure was a smartablate generator, not an ngen, therefore this submission was created and sent.The hardware investigation has begun but it has not been completed at this time.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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a smartablate¿ system rf generator (and the patient experienced 3rd degree burn.The patient had a burn that was not observed directly after the procedure.According to the physician, the patient suffered a 3rd degree burn.The patient was reported to have recovered from the injury.No intervention was provided.The physician stated that healing had already begun by the time the injury was observed.The patient's contact area and indifferent electrode were properly prepared.The indifferent electrode was placed on the lower back, just below the patient¿s back patches.The indifferent electrode used for the procedure is called valleylab rem polyhesive adult patient return electrode.The product is made by covidien.The indifferent electrode was positioned on the patient¿s back as close to the patient¿s heart as possible.There were no air pockets between the skin and the indifferent electrode and that the entire surface area of the product was in contact with the patient¿s skin.There was no conductive gel present on the indifferent electrode.According to lab staff, no conductive gel is typically used.The indifferent electrode was not moist upon opening the packaging.The indifferent electrode is at least 124 cm squared.No error codes were listed on the smartablate generator during this procedure.The medical team moved the grounding pad typically situated on the lower back and switched it to being on the outer thigh of the patient at the doctor's request and they haven't had any problems since.
Additional Manufacturer Narrative
D4 primary udi number has been updated to (b)(4).On 7-aug-2024, the product investigation was completed.Device evaluation details: it was reported by the caller that lab staff notified him that the patient had a burn that was not observed directly after the procedure.Remote support confirmed the unit was performing as intended, no failure was found in the unit.It should be noted that this issue was previously reported under (b)(4).A device history record evaluation was performed for the finished device number g4c-1902, and no internal actions related to the reported condition were identified.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.Manufacturer'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 31; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 19120605
• Report Number: 2029046-2024-50003
• Device Sequence Number: 8230243
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: (01)04260166371390(11)160607(21)G4C-1902
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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 Catalogue Number: M490007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/07/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown