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, the hospital staff found that there was a kink on the proximal part of the penumbra system ace 60 reperfusion catheter (ace60) upon removal from the packaging.The damage to the ace60 was found prior to use and therefore, the ace60 was not used in the procedure.The procedure was completed using a new ace60.
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