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	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: this event was originally reported under manufacturer report number 2029046-2024-00407 under the ngen rf generator, us configuration.However, information received by bwi on 22-mar-2024 confirmed the generator used in the procedure as the smartablate¿ system rf generator (us), not the ngen rf generator, us configuration.Therefore, this report under the smartablate¿ system rf generator (us) was created for submission.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.Importer reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation with a smartablate¿ system rf generator (us) and the patient experienced a skin burn.The adverse event occurred on 03-oct-2023.The physician was unsure what caused the event but suspected it could be an issue with the indifferent electrode.According to the physician, no intervention was provided.The physician stated that healing had already begun by the time the injury was observed, scar remains.According to the physician, the patient's injury status has improved.The indifferent electrode used for the procedure is called valleylab rem polyhesive adult patient return electrode.The product is made by covidien.The serial and lot number of the product used in the procedure is unknown.The patient contact area and indifferent electrode were properly prepared.The indifferent electrode was placed on the patients lower back, just below the back patches.The indifferent electrode was positioned as close to the patient¿s heart as possible.It was believed that 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 cm2.No error codes were listed on the smartablate¿ system rf generator (us) during this procedure.The caller does not believe the patient required extended hospitalization.
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation with a smartablate¿ system rf generator (us) and the patient experienced a skin burn.The investigation was completed on 31-may-2024.No failure was found.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint 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: 19133936
• Report Number: 2029046-2024-50004
• Device Sequence Number: 14616998
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• 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): 06/04/2024
• Report Date (Section F): 03/26/2024

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2024
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; COVIDIEN VALLEYLAB POLY ADULT PATIENT RET ELECT; NGEN PUMP, US CONFIGURATION; UNK_SMART TOUCH UNIDIRECTIONAL SF
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 75 KG