It was reported that a patient was treated for ventricular tachycardia by ablation under general anesthesia with a thermocool® smart touch® sf bi-directional navigation catheter.Post procedure, the bwi product analysis lab identified a hole in the pebax.During surgery, during the invasive procedure, the ablation catheter had a force sensor problem.The catheter was changed and the procedure continued.The procedure length was extended by 5 minutes as a result.No patient consequences were reported.
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Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.The device was connected to carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device 31088827l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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