It was reported that this was a percutaneous intervention (pci) treating a proximal right coronary artery (rca) heavily calcified lesion.During nc trek advancement over a balance middle weight i (bmw) guidewire, just inside the sheath, resistance was met at a guidewire junction.The nc treks distal shaft separated near the balloon connection.The nc trek and separated portion were removed without issue and without requiring intervention.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided regarding this device issue.
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(b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported shaft separation was confirmed; however, the difficulty positioning the device over the guide wire was not confirmed.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 proximal shaft separation appears to be related to circumstances of the procedure; however, a conclusive cause for the reported difficulty positioning the guiding catheter could not be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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