BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM SEPARATOR 041

    MDR report key: 1983842 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00042
    Event Type
    Death
    Date Received
    February 4, 2011
    Date of Event
    May 15, 2009
    Report Date
    June 3, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE WAS DISPOSED OF BY THE HOSPITAL AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. VESSEL PERFORATION IS A KNOWN AND ANTICIPATED COMPLICATION WITH THIS TYPE OF PROCEDURE AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    WHEN THE PROCEDURE STARTED, THE DOCTOR WAS ABLE TO REMOVE THE THROMBUS FROM THE ICA UP TO THE PCOM LEVEL, DESPITE A 360 DEGREE LOOP UNDER THE SCULL BASE. THE NEURON 070 PASSED THE LOOP, AND THE PENUMBRA SYSTEM 041 RE-CANALIZED THE WHOLE ICA. DESPITE THE PASSAGE OF A NORMAL MICRO GUIDE WIRE TO THE MCA LEVEL, IT WAS IMPOSSIBLE TO HAVE THE REPERFUSION CATHETER 041 UP, AND AFTER SOME WORK SUDDENLY PERFORATED THE ICA AT THE PCOM LEVEL. THE DOCTOR DOES NOT KNOW WHAT CAUSED THE PERFORATION AND WILL NOT STOP THE USE OF THE PENUMBRA SYSTEM; HE HAS HAD TOO MANY GOOD RESULTS TO STOP THE USE OF IT. THE DOCTOR SAID, HE "WOULD UNFORTUNATELY REPORT A PERFORATION OF THE RIGHT INTERNAL CAROTID ARTERY DURING THROMBECTOMY OF AN OCCLUDED INTERNAL CAROTID ARTERY WITH A SMALLER THROMBUS IN THE RIGHT M1 SEGMENT." THE PATIENT PASSED AWAY THE NEXT DAY. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2009-00027 WHICH PERTAINS TO PENUMBRA SYSTEM REPERFUSION CATHETER 041.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 041 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F13013

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NEURON DELIVERY CATHETER 070