BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER EXTRA VIEW BALLOON- OVAL

    MDR report key: 2933384 · Received December 21, 2012

    Report

    Report Number
    2647580-2012-00810
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 30, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE DISSECTION BALLOON DID NOT DEPLOY. PATIENT OUTCOME: NIL ADVERSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER EXTRA VIEW BALLOON- OVAL SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P0K1236

    Patients

    Seq Age Sex Outcome Treatment
    1