The actual device concerned was not returned, 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 including the shaft-pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test 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: the balloon may have damaged by the hardened sharp edge and should have been ruptured when the balloon was inflated.While removing it from the patient, the bulky portion of the ruptured balloon was caught on the sheath and could not be pulled back any more.Further attempts to forcibly pull back the device resulted in breakage of the balloon and the tip, and the broken pieces remained in the patient's blood vessel.
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Shiranui hp is an otw-type pta balloon catheter compatible with 0.018 inch guidewire.Shiranui hp has no approval in usa.However, we intend to report this case as the event occurred on the similar device for crosstella otw" (otw type pta balloon dilatation catheter,0.018" guidewire compatible) in us under 510(k)# k160004." the balloon rupture occurred when the balloon was repeatedly inflated.When it was pulled out, the tip of the catheter was broken.The tip of the catheter with distal part of the balloon broke have remained inside the body and it was removed.
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