According to the reporter, the physician observed and reported that the balloon was difficult to deflate (just an observation not a quality issue).It was stated that when the balloon was being removed from the patient, the balloon was caught in the introducer sheath (6 french gauge (fr), cordis) and as result the balloon separated from the catheter and was broken into two pieces (the broke in two pieces refer to the catheter as one piece and the balloon as the second piece.The balloon remained intact).The balloon was retrieved without surgical intervention because it broke within the sheath instead of the vessel.It was stated that to resolve the issue the balloon was removed together with the introducer sheath and the procedure was completed.X-ray/ fluoro was required to check if all pieces were accounted for and the balloon was also examined to ensure it was intact.All pieces were retrieved from the patient.The catheter was not repaired.There was no leak and no luer adapter issue.Tego was not utilized.There was nothing unusual observed on the device prior to use, flushing was done per instruction for use (ifu) and there was no unexpected result, no other products were utilized with the device and no other defects/damages were found on the product.There was no resistance encountered when advancing the device, the device did not pass through a previously deployed stent, the reported balloon was inflated by hand with a syringe, the inflation fluid used was standard contrast fluid mix, the device did not move while inflated, no excessive force was used (detachment was spontaneous), and there was no additional medical intervention required to retrieve the detached item.There was no patient symptoms or complications associated with this event.There was no vessel damage, there was no blood loss and blood transfusion was not required.
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