BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 3MAX SEPARATOR

    MDR report key: 3882199 · Received June 18, 2014

    Report

    Report Number
    3005168196-2014-00398
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    July 1, 2013
    Report Date
    May 19, 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 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. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00397. 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 A 3MAX SEPARATOR. BEFORE THE PROCEDURE, INTRAVENOUS TISSUE PLASMINOGEN WAS NOT ADMINISTERED. DURING THE PROCEDURE, A 3MAX REPERFUSION CATHETER WAS ADVANCED TO THE M2 ALONG WITH ANOTHER MANUFACTURER'S GUIDE WIRE AND GUIDING CATHETER. ASPIRATION WAS DONE WITH A 3MAX SEPARATOR AND 5,500 UNITS OF HEPARIN WERE INJECTED. A POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) INDICATED THAT THE PATIENT WAS FOUND TO HAVE SUBARACHNOID HEMORRHAGE (SAH) AND HAD SEVERAL SYMPTOMATIC EPILEPTIC SEIZURES. THE PHYSICIAN CLOSELY MONITORED THE PATIENT'S CONDITION BUT WITHHELD ANY ADDITIONAL TREATMENT. APPROXIMATELY A MONTH LATER, THE PATIENT RECOVERED. PHYSICIAN'S COMMENT: SINCE THE SAH OCCURRED AROUND THE TARGET VESSEL, THE RELATION BETWEEN THE EVENT AND THE PENUMBRA SYSTEM WAS NOT DENIAL. THE EVENT WAS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358664 PENUMBRA SYSTEM 3MAX SEPARATOR NRY NRY PENUMBRA, INC. F33660

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other