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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During preparation for a thrombectomy procedure, a penumbra system ace 60 reperfusion catheter (ace 60) was found kinked at the proximal shaft upon removal from the packaging.The damage to the ace 60 was found prior to use and, therefore, was not used in the procedure.The procedure was completed using a new ace 60 and a neuron max.
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