The actual device was returned.It was confirmed that the balloon was broken.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 calcified lesion of shunt pta 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 ex is an over the wire type semi-compliant pta balloon catheter compatible with 0.018 inch guidewire.Shiranui ex 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.".
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