The concerned device "metacross otw" is a over-the wire (otw) type pta balloon dilatation catheter compatible to 0.035" guidewire (gw)."metacross otw" is distributed in the us under 510(k) # k152080.The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.Probable cause(s) and our comment: we speculate the reported situation as follows: when the catheter was attempted to be retrieved through the sheath, as the frictional resistance between the balloon and the inner wall of the sheath increased, the catheter could not be retrieved.No nonconformity or abnormality in the manufacturing processes of the device concerned was found, and accordingly, we determine that the event reported was caused by not any defect of the device but the user's handling issues.
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