(b)(4).Visual, functional and scanning electron microscopy imaging inspection/analysis were performed on the returned device.The reported balloon rupture was unable to be confirmed; however, a tear in the outer member was observed and is what likely was perceived as the rupture by the account.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulty and patient effects/additional treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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