BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER

    MDR report key: 3813012 · Received May 15, 2014

    Report

    Report Number
    3005168196-2014-00311
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    January 8, 2014
    Report Date
    April 16, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    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 3005168196-2014-00312. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA C4) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER AND 5MAX SEPARATOR. BEFORE THE PROCEDURE, 18,720,000 UNITS OF INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA) WERE ADMINISTERED TO THE PATIENT. DURING THE PROCEDURE, A 5MAX REPERFUSION CATHETER WAS ADVANCED TO THE C4 ALONG WITH A GT 0.016 INCH GUIDE WIRE THROUGH AN OPTIMO GUIDE CATHETER 9FR. ASPIRATION WAS CONDUCTED WITH A 5MAX SEPARATOR. HEPARIN WAS NOT INJECTED. THE PATIENT DEVELOPED ASYMPTOMATIC SUBARACHNOID HEMORRHAGE (SAH) DURING THE OPERATION. THE PHYSICIAN CLOSELY MONITORED THE PATIENT'S CONDITION BUT WITHHELD ANY ADDITIONAL TREATMENT. PHYSICIAN'S COMMENT: THE EXACT CAUSE OF THE SAH WAS UNKNOWN. I CANNOT SAY FOR SURE THAT THE HEMORRHAGE WAS NOT RELATED TO THE PENUMBRA SYSTEM, BUT FRAGILE BLOOD VESSELS ALSO CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291193 PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F38307

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other