The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material inside pebax due to a hole in the pebax of the catheter.The root cause of the damage on the pebax, it was concluded that it occurred outside the bwi manufacturing facilities.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device number lot 31033754l, and no internal actions related to the complaint were found during the review.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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