The product was disposed of by the hospital and is no longer available for return.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 discarded the device.
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During preparation for a thrombectomy procedure, the hospital staff noticed that the penumbra system ace 68 reperfusion catheter (ace68) was kinked upon removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).The damage to the ace68 was found prior to use, and therefore it was not used in the procedure.The procedure was completed using new ace68.
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