Reportable based on the product analysis completed on (b)(6) 2019.It was reported that insertion and withdrawal difficulty occurred.A percutaneous coronary intervention was being performed on a 75% stenosed, moderately calcified and moderately tortuous lesion in the mid right coronary artery.The 10mmx3.00mm wolverine coronary cutting balloon was used successfully once.After removal, the physician tried to advance it again, but there was severe resistance.When the balloon was advanced into the proximal y-connector, it was unable to cross and the balloon was difficult to remove.After applying force, the balloon was removed, however, the balloon was noted to be damaged/crushed.The procedure was successfully completed with a different device without issue or patient injury.However, the returned product analysis revealed that a shaft break occurred.
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