The investigational analysis completed 12/23/2019.The device was inspected and reddish-brown color was observed under pebax.During the second visual inspection, reddish-brown material was confirmed inside the pebax and a hole was found.The magnetic sensor functionality was tested on carto and the catheter was properly visualized, with no errors were observed.The force sensor feature was tested and it was found to be working properly.The force values were observed within specifications.A manufacturing record evaluation was performed, and no internal actions were identified.The customer complaint cannot be confirmed.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.(b)(4).
|
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a hole on the pebax surface.Initially, it was reported once coming into ablation with the power set to 10 watts or more, a force sensor error was displayed on the carto 3 system.The cable was replaced without resolution.Catheter replacement resolved the issue.No adverse patient consequences were reported.On 12/3/2019, the bwi pal received the device for evaluation.Upon initial inspection, reddish-brown color observed under pebax.The observed reddish-brown color has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Further testing was performed.On 12/19/2019 during a second visual inspection, the bwi pal confirmed the reddish-brown material under the pebax.In addition, a hole was observed.The awareness date has been reset to 12/19/2019.
|