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

Catalog Number M490007

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 01/01/2024

Event Type  Injury  

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 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.

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (US)
• Type of Device: 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
• MDR Text Key: 340313948
• Report Number: 2029046-2024-50003
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M490007
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other