The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and functional tests of the returned device were performed following bwi procedures.Visual analysis revealed that the pebax was broken with internal parts exposed.A microscopic examination was performed, and no foreign material was observed.Deflection testing was performed, and the deflection mechanism failed specifications due to the puller wire was found broken on the handle.Then, a pump and pressure gage test was performed, and the device was irrigating correctly.No water leakage was observed.The root cause of damage on pebax could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30985859l number, and no internal actions related to the reported complaint condition were identified.No foreign material was observed, however, due to the damage on pebax, was confirmed.The deflection issue reported by the customer was confirmed.The water leakage issue could not be replicated during this product investigation.It should be noted that product failure is multifactorial.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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