Internal file number - (b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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.The investigation determined the reported difficulties appears 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.The 3.75 x 20 mm nc trek is being filed under a separate medwatch report #.
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It was reported that the procedure was to treat a saphenous vein graft to the diagonal.The 2.0 x 15 mm mini trek balloon catheter was used for treatment of a lesion in the mid diagonal artery.The 3.75 x 20 mm nc trek balloon catheter was used for treatment of a de novo lesion located in the moderately tortuous, distal diagonal artery and was inflated to 20 atmospheres.There was no difficulty experienced during deflation of the balloons; however, during retraction after use, both balloons met resistance during removal through the y connector; however, were able to be successfully removed.The balloons appeared to be "bunched up";.Both balloons were confirmed to be fully deflated prior to removal through the y-connector.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
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