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.The hospital disposed of the device.
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The patient was undergoing a coil embolization procedure in the aorta using pod packing coils (podj¿s).During the procedure, the physician placed the seven ruby coils and a podj in the target vessel using a non-penumbra microcatheter.While attempting to advance a new podj through the microcatheter, the podj pusher assembly became kinked; therefore, it was removed.The physician then took a picture and determined that the leak was contained and no more coils were needed.Therefore, the procedure was completed at that point.There was no report of an adverse effect to the patient.
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