(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual inspection was performed on the returned device.The reported balloon twisted was not confirmed.The reported inflation issue was not confirmed due to the noted longitudinal rupture on the balloon.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 reported from this lot.The investigation determined the reported inflation issue and twisted balloon, and the noted balloon rupture appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that the procedure was to treat a non-tortuous, mildly calcified, 99% stenosed lesion in the femoral artery.A 9 x 40mm armada 35 was advanced into the patient anatomy and failed to inflate.The balloon was noted to be twisted on itself once it was removed from the patient anatomy.A new armada 35 was used to successfully complete the procedure.There was no adverse patient effect or a reported clinically significant delay in the procedure.The return device analysis found that there was a longitudinal rupture at the distal balloon shoulder.No additional information was provided.
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