BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1213790 · Received October 22, 2008

    Report

    Report Number
    2032545-2008-06800
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. THERE WAS NOT ENOUGH INFO TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE CAPSULE WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN RETURNED, COILED UP IN A SMALL BAG. THE TROCAR NEEDLE WAS NOT ADVANCED. THE PLUNGER WAS ADVANCED BUT NOT ROTATED. THE ANALYST WAS ABLE TO ROTATE THE PLUNGER AND RELEASE THE CAPSULE. THE CAPSULE DID NOT ATTACH.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED TO THE MFR AS A NON-COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q220011

    Patients

    Seq Age Sex Outcome Treatment
    1