BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 4 FR 5 0CM

    MDR report key: 1011623 · Received March 10, 2008

    Report

    Report Number
    2242445-2008-00006
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN, THAT AFTER THE BALLOON WAS INSERTED, A LEAK WAS FOUND UNDER X-RAY. THERE WERE NO REPORTED PT COMPLICATIONS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: BERMAN 4 FR 5 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTL., INC. MF7086910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK