BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 3801042 · Received May 8, 2014

    Report

    Report Number
    3005168196-2014-00280
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    April 13, 2013
    Report Date
    April 8, 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: HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND ARE 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. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00279, 00281, AND 00282. DEVICE WAS DISPOSED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) CHOROID (C4) TO THE RIGHT ACA (A1) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 054/032 AND SEPARATOR 054/032. BEFORE THE PROCEDURE, THE PATIENT WAS GIVEN 20,530,000 UNITS OF INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA). A REPERFUSION CATHETER 054 WAS ADVANCED TO THE C4 ALONG WITH A CHIKAI 0.014 INCH THROUGH AN OPTIMO 9FR. ASPIRATION WAS CONDUCTED WITH A SEPARATOR 054, AND WITH A REPERFUSION CATHETER 032 IN THE A1. THE PATIENT WAS GIVEN 2,000 UNITS OF HEPARIN BY INJECTED. AFTER ASPIRATION EXTRAVASATION WAS CONFIRMED THROUGH ANGIOGRAPHY. THE PHYSICIAN CUT OFF BLOOD FLOW TO THE A1 FOR 5 MINUTES USING THE INFLATED OPTIMO 9FR IN THE ICA. AFTER THAT, ANGIOGRAPHY SHOWED THAT EXTRAVASATION WAS STOPPED. APPROXIMATELY EIGHT DAYS LATER, THE PATIENT EXPIRED. PHYSICIAN'S COMMENT: THE PSC032 PROBABLY DAMAGED THE BLOOD VESSEL WHILE ADVANCING. THE EVENT WAS RELATED TO THE PENUMBRA SYSTEM. EMBOLISM OCCURRED IN THE END OF THE RIGHT ICA. SINCE RECANALIZATION WITH THE PSC054 WAS SUCCEEDED, THE PATIENT HAD ALREADY DEVELOPED FATAL CEREBRAL INFARCT. SO THERE WAS NO IMPROVEMENT IN SYMPTOMS. IN ADDITION TO THE EXTENSIVE CEREBRAL INFARCT, SAH, WHICH WAS COMPLICATED WITH THE PROCEDURE, MIGHT DETERIORATE INCREASED INTRACRANIAL PRESSURE AND HIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277721 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC. F26470

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death