MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SMARTABLATE SYSTEM RF GENERATOR (US); CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M490007

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

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 a paroxysmal atrial fibrillation (afib) ablation procedure with a smartablate¿ system rf generator and a high flow activation problem occurred.It was reported that during the procedure, the smartablate¿ system rf generator lost power when the smartablate pump power was cycled twice.The smartablate pump was rebooted due to it was not delivering high flow irrigation when the smartablate¿ system rf generator began rf delivery.The smartablate¿ system rf generator¿s fuses were exchanged, and the power was restored.The case continued successfully.No patient consequences were reported.A service for the smartablate¿ system rf generator was declined.Multiple attempts were made to obtain further information regarding this event; however, no response was received.With the information available, this event is mdr-reportable for high flow rate activation problem with ablation.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On 5/25/2020 biosense webster inc.Received additional information about the event from the biosense webster inc.Representative that the pump had no problems with power loss after the fuses were replaced, however, the smartablate¿ system irrigation pump still fails to turn on following the smartablate¿ system rf generator when the ¿stop¿ button is pressed on smartablate¿ system rf generator during boot up.On 5/28/2020 additional follow-up was done to clarify the reported event of the smartablate¿ system rf generator having a high flow activation problem.The bwi representative acknowledged there were some misstatements captured in the event description.Bwi representative indicated they have not had the issue of not being able to irrigate correctly when needed and have not had any problems flushing.The actual problem was getting the equipment powered on properly.Upon trying to start-up the smartablate¿ system rf generator and the smartablate¿ system irrigation pump, the smartablate¿ system irrigation pump did not power on as expected.The smartablate¿ system rf generator was turned on first and once it powers on, the stop button was pressed to activate power to the smartablate¿ system irrigation pump; however, the smartablate¿ system irrigation pump did not fully power on and it only show a gray screen.The bwi representative had to power down both systems and unplug the interface cable before powering the smartablate¿ system rf generator back on.Since they had to restart the smartablate¿ system rf generator so many times, they end up blowing the fuses on the smartablate¿ system rf generator.The fuses were replaced, and the system restored for use.The bwi representative clarified that once the units are on, they do not shut off on their own and there were no other deficiencies during use.Based on the information received, this event is being reassessed as not mdr reportable since a start-up and communication issues with the smartablate¿ system rf generator make the device inoperable.These would be highly detectable and the most likely consequence would be an intraprocedural delay.The potential risk that the start-up or communication issues could cause or contribute to a death or serious deterioration in state of health are remote.The h6.Device code of 2954 (improper flow or infusion) is no longer applicable to this event.Manufacturer¿s ref #: (b)(4).

• Brand Name: SMARTABLATE SYSTEM RF GENERATOR (US)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9921058
• MDR Text Key: 201890194
• Report Number: 2029046-2020-00516
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• PMA/PMN Number: P990071/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M490007
• Device Catalogue Number: M490007
• Date Manufacturer Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1