As reported, during insertion, a sleek 3.0mm x 150mm l=155cm balloon catheter was caught up on the strut of an unknown stent which caused the distal tip of the balloon to separate from the body of the balloon catheter.A second unknown stent was deployed to hold the remaining section of balloon in place.This was during a peripheral procedure in which the target vessel was the superficial femoral artery (sfa).The sleek balloon catheter was prepped per the instructions for use (ifu) and no anomalies were noted during the prep.No kinking or bending occurred prior to the separation of the balloon, and the balloon did not seem to stick to a stent.The device will not be returned for evaluation.
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