Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and screening test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed a hole in the pebax and foreign reddish material was observed inside it.A screening test was performed, and the device was visualized and recognized correctly; no force issues were observed, and since the sensor values were found within specifications, the event described by the customer could be related to the reddish material inside the pebax, however, the root cause of the damage on the pebax could not be determined; it was concluded that it occurred outside the bwi manufacturing facilities.A manufacturing record evaluation was performed for the finished device 31055915l, and no internal action was found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The instructions for use 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 ref.# (b)(4).
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