BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 3813368 · Received May 15, 2014

    Report

    Report Number
    3005168196-2014-00313
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    November 11, 2013
    Report Date
    April 16, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    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 3005168196-2014-00314. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA, M2) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER AND SEPARATOR. BEFORE THE PROCEDURE, THE PATIENT WAS GIVEN 16,380,000 UNITS OF INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA) AND UK WAS INJECTED. DURING THE PROCEDURE, A 3MAX REPERFUSION CATHETER WAS ADVANCED TO THE M2 ALONG WITH A GT 0.016 INCH GUIDE WIRE THROUGH A ROADMASTER GUIDING CATHETER 6FR. ASPIRATION WAS CONDUCTED WITH A 3MAX SEPARATOR. THE PATIENT WAS THEN GIVEN 2,000 UNITS OF HEPARIN BY INJECTED. AFTER USING THE 3MAX SEPARATOR, THE PHYSICIAN OBSERVED THAT RADIOPAQUE DYE OOZED OUT OF THE ARTERY. POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SHOWED HEMORRHAGE IN THE NUCLEUS BASALIS AND DETERIORATING INTRACRANIAL HEMORRHAGE. THE PHYSICIAN ADMINISTERED ONE ML OF PROTAMINE AND 50ML OF NORMAL SALINE WERE INJECTED. SUBSEQUENTLY, THE PATIENT EXPIRED THE SAME DAY OF THE PROCEDURE. PHYSICIAN'S COMMENT: THE CAUSE OF THE EVENT WAS PERFORATION BECAUSE EXTRAVASATION OCCURRED AFTER USE OF THE SEPARATOR. THE EVENT WAS RELATED TO THE PENUMBRA SYSTEM. I PERFORATED AFTER INJECTING T-PA AND UK. IT DETERIORATED INTRACRANIAL HEMORRHAGE, WHICH CAUSED THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292023 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F35616

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death