MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ SYSTEM RF GENERATOR (EU); SIMILAR DEVICE M490007, PMA # P990071/S017

Catalog Number M4900107

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient ((b)(6) kg) underwent a his bundle ablation procedure with a smartablate¿ system rf generator (eu) and suffered a third-degree skin burns.Post-procedure, it was noticed that the patient had third degree skin burns, 3 lesions (2 lesions = 3 cm diameter, 1 lesion = 1-2 cm diameter) where a fiab (f7905w/v, 134 cm²) indifferent electrode was placed at the abdominal position (skin folds).Medical intervention was required, patient was given flammazine.Extended hospitalization was not required.The physician¿s opinion regarding the cause of the adverse event is that it was related to patient¿s condition.There¿s no information regarding patient¿s outcome.There was bad contact due to skin folds (obese patient).Upon opening the package for the grounding pad, the conductive gel was present on the indifferent electrode and it was not moist.The entire surface area of the grounding pad was not in complete contact with the patient¿s back.There were air pockets present between the skin and the indifferent electrodes.The indifferent electrodes were not positioned at a location on the back that was close to the heart.It is unknown if the patient contact area and the indifferent electrodes were properly prepared per the indifferent electrode instructions for use.The indifferent electrodes were used with the smartablate¿ system rf generator (eu) at least =124 cm² maximum time.It was indicated that the indifferent electrodes did not contribute to this event.No biosense webster, inc.Product malfunctions were reported.The impedance reached the cut-off (300 ohms) and triggered an alarm and was disabled.The generator settings were: temperature target 65°c/ cut off 90°c, max power 70 w, impedance: cut-off 250 ohm, min cut off 50 ohm.The high impedance issue was assessed as not reportable as the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

On 10/16/2019, it was noticed that the concomitant product was inadvertently omitted from the 3500a initial mdr submitted to fda on 10/16/2019.The product has now been added to concomitant med products.Manufacturer's reference # (b)(4).

Manufacturer Narrative

It was reported that a 60-year-old male patient (100 kg) underwent a his bundle ablation procedure with a smartablate¿ system rf generator (eu) and suffered a third-degree skin burns.Post-procedure, it was noticed that the patient had third degree skin burns, 3 lesions (2 lesions = 3 cm diameter, 1 lesion = 1-2 cm diameter) where a fiab (f7905w/v, 134 cm²) indifferent electrode was placed at the abdominal position (skin folds).Medical intervention was required, patient was given flammazine.Extended hospitalization was not required.The physician¿s opinion regarding the cause of the adverse event is that it was related to patient¿s condition.There¿s no information regarding patient¿s outcome.There was bad contact due to skin folds (obese patient).Upon opening the package for the grounding pad, the conductive gel was present on the indifferent electrode and it was not moist.The entire surface area of the grounding pad was not in complete contact with the patient¿s back.There were air pockets present between the skin and the indifferent electrodes.The indifferent electrodes were not positioned at a location on the back that was close to the heart.Follow up was performed and there were no issues found related to the device.The reported issue was related to user error.The issue reported was not related to the manufacturing process.The certificate of conformance (coc) was reviewed.It was verified that the device was manufactured in accordance with the documented specifications and procedures.Manufacturer's reference # (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (EU)
• Type of Device: SIMILAR DEVICE M490007, PMA # P990071/S017
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9199876
• MDR Text Key: 162598402
• Report Number: 2029046-2019-03770
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M4900107
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FIAB (F7905W/V, 134CM²) INDIFFERENT ELECTRODE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 100