The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, electrical and screening test of the returned device was performed following bwi procedures.Visual inspection was performed and the pebax component at the tip area was observed broken leaving internal parts exposed.The device was connected to the carto 3 system and error 106 and electrical noise were observed due to the damage on the pebax.A manufacturing record evaluation was a manufacturing record evaluation was performed for the finished device number lot 31164108m and no internal action related to the complaint were found during the review.The damage on the pebax could be related to the force and electrical issues reported by the customer therefore, customer complaint was confirmed.The potential cause of the broken condition cannot be determined, it could be related to the handling of the device after procedure however, this cannot be conclusively determined.The instructions for use (ifu) contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.For the reported force issue the ifu states the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.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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It was reported that the patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and post procedure the bwi product analysis lab identified a broken pebax and internal components exposed.During the procedure, the force value could not be zeroed.The signal interference noise was only observed on the carto system.The medical team was still able to monitor the patient's heart rhythm via other devices (body surface, anesthesia monitor, defibrillator).A second catheter was used to complete the operation.There was no adverse event reported on patient.
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