(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.A visual and dimensional inspection was performed on the returned device.The reported kinked shaft and shaft detachment were confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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It was reported the procedure was performed to treat a lesion in the obtuse marginal vessel with moderate calcification.The 2.0 x 15 mm nc trek balloon dilatation catheter (bdc) was advanced for dilatation.During advancement of the nc trek, resistance was met with the calcification and the proximal shaft kinked, then separated outside the anatomy.This was prior to reaching the lesion.The nc trek was removed without issue and a non-abbott bdc was used for successful dilatation.A 3.0 x 8 mm xience alpine stent was successfully deployed to treat the lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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