BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 3885102 · Received June 19, 2014

    Report

    Report Number
    3005168196-2014-00402
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    July 29, 2012
    Report Date
    May 20, 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 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 3005168196-2014-00401. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ON (B)(4) 2014, THE MANUFACTURER RECEIVED THE REPORTERS NAME AND TITLE. NO FURTHER INFORMATION IS AVAILABLE; THEREFORE, THE MANUFACTURER IS CLOSING THE CASE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 032 AND SEPARATOR 032. BEFORE THE PROCEDURE INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA) WAS NOT ADMINISTERED. DURING THE PROCEDURE, A REPERFUSION CATHETER 032 WAS ADVANCED TO THE M2 ALONG WITH ANOTHER MANUFACTURER'S GUIDE WIRE AND GUIDING CATHETER. ASPIRATION WAS DONE WITH A SEPARATOR 032 AND 4,000 UNITS OF HEPARIN WERE INJECTED. THE PATIENT DEVELOPED SYMPTOMATIC INTRACRANIAL HEMORRHAGE. THE PHYSICIAN CLOSELY MONITORED THE PATIENT'S CONDITION BUT WITHHELD ANY ADDITIONAL TREATMENT. APPROXIMATELY A WEEK LATER, THE PATIENT HAD NOT RECOVERED. THE PATIENT LEFT THE HOSPITAL APPROXIMATELY A MONTH LATER. PHYSICIAN COMMENTS: IT COULD NOT BE DENIED THAT THE EVENT WAS RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE, BECAUSE HEMORRHAGE OCCURRED IN THE RECANALIZED AREA. RECANALIZATION IN THE OCCLUDED PART WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360695 PENUMBRA SYSTEM SEPARATOR 032 NRY NRY PENUMBRA, INC. F24771

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other