(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 and complaint history could not be conducted because the lot number was not provided.The investigation determined the reported difficulties 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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It was reported that the procedure was performed to treat a lesion in the left circumflex artery with heavy calcification.Following atherectomy, a 2.50 x 15 mm nc trek rx balloon dilatation catheter (bdc) was attempted to be advanced; however, failed to cross the lesion due to the patient anatomy.The shaft of the bdc kinked and separated.The site of the separation was outside of the patient anatomy and therefore the distal shaft of the bdc was simply manually removed.A new unspecified trek bdc was used to complete pre-dilatation and a xience sierra stent was successfully deployed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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