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

Model Number M490007

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/17/2022

Event Type  Injury  

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.Manufacturer's ref.#(b)(4).

Event Description

It was reported that a 67-year-old female patient (date of birth (b)(6) 1955, weighing 132 kilograms) underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ system rf generator (us) and the patient suffered a burn with blisters where grounding pad was.It was reported that a burn on the grounding pad site was discovered on the patient after the procedure was completed and the patient was in the recovery room.There were blisters discovered on the patient where the grounding pad was placed.Burn ointment was applied in recovery room.The patient outcome of the adverse event is fully recovered with no residual effects.The patient did not require extended hospitalization because of the adverse event.The patient was reported to be in stable condition.The physician¿s opinion on the cause of this adverse event is that it was a bwi product malfunction, the grounding pad came off the patient and when rf was delivered left a burn on the patient's back.

Manufacturer Narrative

On 9-nov-2022 additional information was received indicating the burn classification is 2nd degree with blistering, patient is fine now.As far as the bwi representative is aware that the only intervention provided was ointments.Maestro rf ablation non split neutral electrode was used.No prep was done for indifferent electrode.Electrode was placed on the middle of the spine just above the buttocks.Indifferent electrode was placed in the middle of spine above buttocks.The indifferent electrode was positioned at the lower back.The entire surface area of the grounding pad was not in complete contact with the patient¿s back, the patient was sweaty and the electrode peeled partly off of the back.Upon opening the package for the grounding pad, conductive gel was present on the indifferent electrode.Upon opening the package for the grounding pad, the indifferent electrode was moist.No generator issues noted.Generator settings were 35 -40 watts.Manufacturer's ref.# (b)(4) correction: after further review of this event it was determined that this complaint should have been considered as a patient event non-serious and not mdr reportable from the initial reported event since it was not reported that medical/surgical intervention or prolonged hospitalization was required to prevent or minimize permanent damage to the patient.As such, this event will no longer be considered as a serious injury and will no longer be considered mdr reportable.Field f10.Medical device problem code, has been updated from patient device interaction problem (a01) to appropriate term/code not available (a27) to represent a patient event that is non-serious.

• 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: 15795260
• MDR Text Key: 303631748
• Report Number: 2029046-2022-50013
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2022,11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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: 11/09/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2022
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 132 KG