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 Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

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.Additionally, 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 patient underwent paroxysmal atrial fibrillation ablation procedure using the smartablate¿ system rf generator and suffered a localized 2nd degree burn on their lower back requiring local cream application.The event occurred after use of biosense webster products.The burn was located where the indifferent electrode (covidien valleylab ref e7507) was attached to lower back to close the ablation circuit.This electrode was connected to the smartablate¿ system rf generator and during the procedure no alarm message reported, the impedance values were between 120 and 200 ohms (normal) which indicated that the circuit was closed (if opened the generator would not deliver the radiofrequency.The representative did not know if the plate was correctly attached.In the physician¿s opinion the event was related to patient condition and resulted from the indifferent electrode which could have had a bad contact since the patient was overweight.The physician thought the problem may be related to the smartablate¿ system rf generator because the device did not display an error message.So, this absence of alert message incriminates the smartablate¿ system rf generator.He also feels that the issue is probably caused by the plaque which was stuck on a skin fold or a bulge.The indifferent electrode was attached as close to the heart as possible.The indifferent electrode was properly prepped but may have had patch on a bead or skin fold.The nurse in charge of patient installation didn¿t notice anything.The provided treatment was local burn cream.The patient¿s outcome is improved and they are fine.No extended hospitalization was required.There was no error displayed by the smartablate¿ system rf generator.Dashboard, vector and visitag features were used for force visualization.Visitag settings were 3mm/3sec.Additional visitag filters were force over time (fot) 25% with color options for ablation index.The smartablate¿ system rf generator parameters were: impedance max cut off: 250; min cut off: 50; spike: 50 power: 20 to 50w, duration per ablation: min time : 5 sec max time: 60sec (20w) / 30sec (40w), total rf time: 1661sec.The smartablate¿ system rf generator¿s instructions for use (ifu) states that the entire surface of the indifferent electrode must be as close as possible to the operating field and must have fully reliable contact with the patient's body.If a solid indifferent electrode detaches from the patient's skin, no alert is triggered.When using a solid indifferent electrode, the hospital staff is responsible for ensuring proper contact of the electrode with the patient¿s skin.If a solid (non-split) indifferent electrode is used and the electrode partially detaches itself, no alert is triggered.The danger of a skin burn under the indifferent electrode is thus increased.This event is not considered to be a product malfunction, however, will be conservatively reported under the smartablate¿ system rf generator as a patient event.

Manufacturer Narrative

On (b)(6)2020, it was noticed that code "1757" (burn(s)) was incorrectly reported on the 3500a initial medwatch report under field h6.Patient code.The correct code for this adverse event is ¿2694¿ (second-degree burn).H6.Patient code field has been properly populated.No new information is available, however, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent paroxysmal atrial fibrillation ablation procedure using the smartablate¿ system rf generator and suffered a localized 2nd degree burn on their lower back requiring local cream application.The event occurred after use of biosense webster products.The burn was located where the indifferent electrode (covidien valleylab ref e7507) was attached to lower back to close the ablation circuit.This electrode was connected to the smartablate¿ system rf generator and during the procedure no alarm message reported, the impedance values were between (b)(4) and (b)(4) ohms (normal) which indicated that the circuit was closed (if opened the generator would not deliver the radiofrequency.The representative did not know if the plate was correctly attached.In the physician¿s opinion the event was related to patient condition and resulted from the indifferent electrode which could have had a bad contact since the patient was overweight.The physician thought the problem may be related to the smartablate¿ system rf generator because the device did not display an error message.So, this absence of alert message incriminates the smartablate¿ system rf generator.He also feels that the issue is probably caused by the plaque which was stuck on a skin fold or a bulge.The indifferent electrode was attached as close to the heart as possible.The indifferent electrode was properly prepped but may have had patch on a bead or skin fold.The nurse in charge of patient installation didn¿t notice anything.The provided treatment was local burn cream.The patient¿s outcome is improved and they are fine.No extended hospitalization was required.Device evaluation details: device evaluation has been completed.The device was evaluated, and no error was found.The device was performing within specification.The device was also subjected to preventative maintenance, safety and functional testing and all tests passed.No device malfunction found.The complaint was not confirmed.Additionally, the 4.Device manufacture date has been provided and field has been populated with(b)(6)2016.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(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: 9805961
• MDR Text Key: 191844745
• Report Number: 2029046-2020-00375
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• 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: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; COVIDIEN VALLEYLAB INDIFFERENT ELECTRODE PATCH; LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE PUMP KIT-WW; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Other; Required Intervention