(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: whisper, stent: 3.0x26mm resolute, guide catheter: ar1.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 difficulty appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.User facility medwatch report mw5074585.
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It was reported that the procedure was to treat an 80% stenosed lesion in the right coronary artery.A 3.0x8mm nc trek balloon dilatation catheter (bdc) was being inserted for post-dilatation of a non-abbott stent; however, blood was noted at the connection point and it was decided to remove the bdc.The shaft separated inside the guiding catheter while being removed.The entire intervention system was removed as a unit.Using a new guide wire and guide catheter, a non-abbott stent was implanted to successfully complete the procedure with 0% residual stenosis and timi 3 flow.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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