There was no product returned for this complaint.No returned product evaluation could be completed.An image was sent by the account.A manufacturing record review was completed and no onconformances were related to this lot therefore, supporting the device met material, assembly and performance specifications.The tip appears to be intact however, the separation of the shaft of the catheter which is significantly faraway from the tip.Case details were reviewed.A patient underwent a thrombus extraction in peripheral artery.The event description states pronto was used in a heavily calcified artery.Tip broke off during withdrawal.Additional information was requested from the account.A response was received.The artery in which the catheter was used was sfa and popliteal artery.Per ifu pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary vasculature.The following warning and precaution were noted never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, damage to the catheter, or vessel perforation exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.It is unknown if the distal tip experienced resistance when used against a calcified artery causing separation.The tip was snared out successfully.The procedure outcome was extensive distal embolization.Ifu states embolism is a potential adverse effect that may be associated with the pronto v4 extraction catheter.Patient was brought back after 3 days for a thrombectomy and embolectomy procedure.The patient condition is improving and fine.
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