The product was not returned for evaluation.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: 3005168196-2016-00287.The hospital disposed of the device.
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The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia), superior gluteal artery (sga) and inferior gluteal artery (iga) using penumbra coils 400 (pc400 coils) and a px slim delivery microcatheter (px slim).During the procedure, the physician delivered a total of nine pc400 coils and another manufacturer's coils into the aneurysm using a px slim.While attempting to advance a tenth pc400 coil through the px slim, the physician met resistance and removed the pc400 coil from the patient.While on the back table, the physician confirmed that the pc400 coil could be advanced out of its introducer sheath and manipulated successfully.Therefore, the physician removed the px slim from the patient and attempted to deliver the same pc400 coil using a new px slim; however, resistance was met again and the pc400 coil was removed.While on the back table, the physician attempted to advance the pc400 coil out of its introducer sheath; however, resistance was met and the coil was unable to advance out of its introducer sheath.The procedure was completed using a new pc400 coil and the second px slim.There was no report of an adverse effect to the patient.
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