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 disposed of the device.
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During preparation for a thrombectomy procedure, the hospital staff noticed that the penumbra system 3max reperfusion catheter (3maxc) was kinked near the hub upon removal from its packaging hoop.The kinked 3maxc was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new 3maxc.
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