Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.After leaving the pressurized balloon catheter soaking in warm water bath overnight, the balloon inflated and maintained pressure of 14atm.There was no leak noted.Additionally, it was noted that the shaft was stretched proximal to the proximal seal.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that there are two images attached to this report, which may show a pre and post image of which looks like the target lesion in the tibial artery.However, the two images are different views/angles of the supposed lesion and does not clearly show the bdc within the lesion, if it is in the vessel at all.Without knowing more details on what equipment/products were used to treat the lesion and without knowing more details on the lesion morphology (calcification, tortuosity, percent stenosis), as well as not knowing if the bdc was prepped per ifu, a conclusion for probable cause of the event cannot be made.The noted stretched shaft was possibly due to manipulation of the device during preparation.The investigation was unable to determine a conclusive cause for the reported inflation issue.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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