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

Model Number M490007

Device Problem Device Remains Activated (1525)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

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, is other additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a smartablate¿ system rf generator and a remote problem was encountered wherein ablation could not be stopped.It was reported that during an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure, the rf would not turn off when the remote was used.The ablation stopped after the stop button on the remote was pushed several times.The remote had to be disconnected to complete the procedure.The generator was used in temperature control mode, the temperature was at 40 degrees and the power at 50 watts.The foot pedal was not used.No patient consequences were reported.

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a smartablate¿ system rf generator and a remote problem was encountered wherein ablation could not be stopped.It was reported that during an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure, the rf would not turn off when the remote was used.The ablation stopped after the stop button on the remote was pushed several times.Device evaluation details: the device evaluation has been completed.The smartablate¿ system rf generator was analyzed.No malfunction was found with the start and stop button of the generator.The unit was found to be working within specification.The smartablate¿ system rf generator remote control was also analyzed.The reported issue could not be duplicated.No malfunction was found with the start and stop buttons of the remote.However, the user interface of the remote was defective.The defective user interface is not related to customer complaint.The remote was repaired and issue was resolved.The device was also subjected to planned maintenance, safety and functional testing and all tests passed.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.Manufacturer¿s ref # (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9599131
• MDR Text Key: 196064499
• Report Number: 2029046-2020-00104
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1