The account alleges that during an embolization procedure for internal iliac artery the tip of the catheter detached within the patient.The catheter was inserted from femoral artery and delivered to the internal iliac artery.During the procedure, a guidewire penetrated the side of the tip of the catheter, causing the tip detachment.It was found that the wire went out from the catheter before reaching its tip hole.The physician moved the wire backward and forward within the catheter several times, and it was found that the wire deviated from the catheter every time.Thus, the catheter was attempted to be pulled backward.At that time, the detachment was confirmed.The major portion of the catheter was withdrawn out, and it was found to be broken off at the junction between the black tip and the purple shaft.The vessel had slight calcification as well as tortuosity.The detached portion has been remaining within iliolumbar artery, and it has not been retrieved due to a physician's decision.
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The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
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