(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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(b)(4).Visual analysis was performed on the returned device.The reported balloon rupture was confirmed.The difficulty removing was not tested due to the condition of the device.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 incidents from this lot.It should be noted that the indication for use listed in the armada 35 instruction for use states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.It could not be determined if using the armada 35 to treat the subclavian contributed to the difficulties.A definitive cause for the rupture could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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