The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-01389.
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The patient was undergoing a coil embolization procedure to treat an anterior carotid artery (aca) aneurysm using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced the smart coil in the target vessel using a non-penumbra microcatheter, but while attempting to detach the smart coil using the handle the smart coil failed to detach.It was reported that the black alignment zone (pet lock) was separated enough; however, upon visual and fluoroscopic inspection, the physician noticed that the smart coil was not successfully detached.The physician then made a couple of more attempts; however, the smart coil would still not detach.Therefore, the smart coil was removed and the procedure was completed using seven non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
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