BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 3090631 · Received May 2, 2013

    Report

    Report Number
    3005168196-2013-00159
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 2, 2013
    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 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 DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING TREATMENT FOR THROMBOTIC INFARCTION IN THE PROXIMAL LEFT M1. ASPIRATION WAS DONE WITH THE PENUMBRA SYSTEM AND THE ROUTE TO THE DISTAL M1 WAS REOPENED. EXTRAVASATION IN THE MCA WAS OBSERVED ON ANGIOGRAPHY (ACT SCORE: OVER 400). THE OPERATION WAS CARRIED ON AFTER THE ACT SCORE DROPPED DOWN TO 280. A PART OF M2 WAS RECANALIZED. THE PATIENT EXPERIENCED MINOR HEADACHE AND NAUSEA. SHE CHANGED CONDITION SUDDENLY ONE HOUR AFTER BEING TRANSFERRED TO POST-SURGICAL TREATMENT UNIT. HERE ENLARGEMENT OF HER PUPILS AND AN INCREASE IN INTRACRANIAL PRESSURE WERE OBSERVED. SHE SUFFERED CEREBRAL HERNIATION AND WAS MONITORED. PHYSICIAN'S COMMENT: THE DEVICES WERE USED CORRECTLY ON AN ANATOMICAL BASIS. THE EXTRAVASATION OCCURRED WHILE THE PSS032 WAS APPLIED. THE CAUSE OF THIS PERFORATION COULD NOT BE REVEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191752 PENUMBRA SYSTEM SEPARATOR 032 NRY NRY PENUMBRA, INC. F25958

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other