BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 3885105 · Received June 19, 2014

    Report

    Report Number
    3005168196-2014-00408
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    October 15, 2012
    Report Date
    May 23, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DISSECTION IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY (BA) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 054 A REPERFUSION CATHETER 032. BEFORE THE PROCEDURE, TWENTY MILLION UNITS OF INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA) WERE ADMINISTERED. DURING THE PROCEDURE, A REPERFUSION CATHETER 054 AND REPERFUSION CATHETER 032 WERE ADVANCED COAXIALLY TO THE BA ALONG WITH ANOTHER MANUFACTURERS GUIDE WIRE AND GUIDING CATHETER WHEN THE ARTERY WAS PERFORATED WITH THE REPERFUSION CATHETER 032. SUBSEQUENTLY, THE PATIENT HAD AN INTRACRANIAL HEMORRHAGE WHERE COIL EMBOLIZATION WAS NECESSARY TO STOP THE HEMORRHAGE. APPROXIMATELY, TWO DAYS LATER THE PATIENT EXPIRED. AN AUTOPSY WAS NOT PERFORMED; HOWEVER, IT WAS ASSUMED THAT THE CAUSE OF DEATH WAS THE DETERIORATING INFARCT CONDITION. PHYSICIANS COMMENT: SINCE THE INTRACRANIAL HEMORRHAGE CAUSED BY PERFORATION WITH THE PENUMBRA SYSTEM, IT WAS RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360652 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC. F24022

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death