BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1030964 · Received April 17, 2008

    Report

    Report Number
    2032545-2008-02008
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 17, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE DEVICE WAS RETURNED COILED UP AND WITH THE CAPSULE SEPARATED FROM THE DELIVERY SYSTEM. THE CAPSULE TROCAR NEEDLE FAILED TO ADVANCE AND NO BLOOD OR TISSUE WAS PRESENT. THE PLUNGER HAD BEEN FULLY DEPRESSED AND BOTH THE PUSH WIRES HAD SMALL BENDS IN THEM. THE ANALYST HAD DIFFICULTY TAKING THE HANDLE APART AND OBSERVED THAT THERE WAS EXCESS GLUE. THE NEEDLE WAS SLIGHTLY SLANTED AND DIFFICULT TO ADVANCE MANUALLY. THERE WAS ALSO EVIDENCE THAT THE NEEDLE HAD SLID OFF OF THE THRUST TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT ATTACH TO THE PATIENT'S ESOPHAGUS. THE CAPSULE FELL OFF IN THE PATIENT'S MOUTH. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q216408

    Patients

    Seq Age Sex Outcome Treatment
    1