For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.There were 5 bends noted along the length of the shaft and a kink noted on the inner.The distal tip was slightly flattened from its midpoint to the point at the distal cone.It is unlikely that any of these issues contributed to the failure to advance issue reported.Therefore, failure to cross the lesion issue was inconclusive for the device.The device was labeled for single use.A root cause has not been determined.The device was labeled for single use.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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