BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELOCITY DELIVERY MICROCATHETER

    MDR report key: 4820230 · Received June 4, 2015

    Report

    Report Number
    3005168196-2015-00574
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    November 18, 2015
    Report Date
    March 3, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 07/06/2016 INDICATED THAT THE VASOSPASM OCCURRED ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    CONCLUSION: VASOSPAM 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 3005168196-2015-00575. DEVICE WAS DISPOSED OF BY HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A VELOCITY DELIVERY MICROCATHETER AND A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. POST PROCEDURE, THE PATIENT EXPERIENCED A MILD VASOSPASM AS A NON-SERIOUS ADVERSE EVENT AND ANEMIA AS A NON-SERIOUS ADVERSE EVENT. THE VASOSPASM EVENT WAS ADJUDICATED TO HAVE A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM, PROBABLE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE, AND UNRELATED RELATIONSHIP TO THE INDEX STROKE. THE VASOSPASM EVENT WAS EVALUATED AS RESOLVED WITHIN THE SAME DAY. THE ANEMIA EVENT WAS ADJUDICATED WITH AN UNCERTAIN RELATIONSHIP TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE, AND UNRELATED RELATIONSHIP TO THE INDEX STROKE. AT ONE-WEEK POST-OP, THE PATIENT WAS DOING WELL CLINICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361608 VELOCITY DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F45313

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other