The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, of the returned device were performed following bwi procedures.Visual inspection was performed and reddish material and a hole were observed in the pebax component.This could be related to the handling and/or manipulation during the procedure; however this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device [ 31119484l] number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.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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