BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2040316 · Received February 15, 2011

    Report

    Report Number
    3005168196-2011-00120
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR EVAL AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    DURING TREATMENT OF A PT WITH AN UNRUPTURED MCA ANEURYSM, THE PHYSICIAN FILLED THE ANEURYSM WITH THREE PENUMBRA 400 COILS. UPON DEPLOYING THE FOURTH COIL, IT BECAME APPARENT THAT TOO LONG A LENGTH HAD BEEN CHOSEN BECAUSE THE COIL BEGAN HERNIATING OUT INTO THE PARENT ARTERY. MOST OF THE COIL WAS RETRACTED INTO THE CATHETER. RESISTANCE WAS FELT WHILE RETRACTING THE LAST 2CM OF THE COIL AND THE COIL THEN SEPARATED FROM THE PUSHER. THE COIL WAS REMOVED WITHOUT ANY HARM TO THE PT AND THE PROCEDURE WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F19350

    Patients

    Seq Age Sex Outcome Treatment
    1