The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2018-02049.
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The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using a penumbra smart coil handle (handle) and penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil in the target vessel using a non-penumbra microcatheter and attempted to detach it using a handle; however, the coil failed to detach.After two failed attempts, the physician manually pulled the smart coil¿s black alignment zone (pet lock) apart; however, the smart coil was still coming back with the pusher assembly when the physician pulled back to remove.It was reported that after pulling approximately one and half centimeters of the smart coil inside the microcatheter, the smart coil unintentionally detached.Therefore, the physician tried to push the smart coil with its pusher assembly but it did not advance past a certain point.The physician then tried to push the smart coil with a wire but the smart coil did not advance past the same point in the microcatheter.Therefore, the physician pulled the catheter back, leaving one and half centimeters of the smart coil tail outside the target vessel.The procedure was completed by holding the tail of the smart coil against the wall of the vessel using a stent device.There was no report of an adverse effect to the patient.
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