Based on a review of the returned device, the reported failure was confirmed.The device was received with a portion of the balloon catheter missing.Based on the description of the event, a portion of the device remained inside the patient.All other aspects of the device remained intact, with no other signs of physical damage on the balloon.It was reported that the physician encountered difficulties attempting to cross the lesion, including attempting to open the lad lesion using a non-compliant (nc) balloon without success.It is possible that anatomical factors contributed to the difficulties to remove and subsequent detachment of the balloon catheter components; however, this cannot be definitively confirmed without a review of the intraoperative imaging.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.
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A shockwave c2 coronary lithotripsy (ivl) device was successfully used to treat a lesion in the left anterior descending (lad) artery.The physician attempted to open the lad lesion using a non-compliant (nc) balloon without success.The c2 catheter was prepped and inserted into the patient.Following balloon inflation and initiation of ivl, the balloon lost pressure after 3 pulses.The balloon was deflated and attempts to remove the balloon were unsuccessful, leaving a portion of the balloon jailed against the vessel wall.Half of balloon remained attached on the vessel wall, and the physician was unable to recross the lesion with the guidewire and elected to convert the patient to surgical bypass.There have been no additional patient sequelae reported.
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