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.
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The patient was undergoing a thrombectomy procedure in the distal internal carotid artery (ica) using a penumbra system ace 68 reperfusion catheter (ace68), a neuron max 6f 088 long sheath (neuron max), and a guidewire.During the procedure, the physician inserted the neuron max and ace68 into the patient, then connected a syringe to the ace68; however, no aspiration was observed.Subsequently, the physician realized that there was no negative pressure.The physician then made another attempt, but same issue occurred.Therefore, the ace68 was removed and flushed on the back table.While flushing the ace68, the physician found a leak approximately 1-2 centimeters near the distal tip.Therefore, the ace68 was no longer used.The procedure was completed using a new ace68, the same neuron max, and the same guidewire.There was no report of an adverse effect to the patient.
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