BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1022453 · Received March 31, 2008

    Report

    Report Number
    2032545-2008-01683
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED A PROCEDURAL NON-CONFORMANCE. THE PLUNGER HAD BEEN OVER-ROTATED AND BROKE OFF. THE CAPSULE WAS STILL ATTACHED TO DELIVERY SYSTEM. THE TROCAR NEEDLE WAS FULLY ADVANCED WITH BLOOD/TISSUE PRESENT. THE ANALYST WAS ABLE TO GRAB THE REMAINING PIECE OF THE PLUNGER SHAFT AND PULLED IT BACK RELEASING THE CAPSULE EASILY. THE DEVICE IS INCLUDED IN THE BRAVO PH CAPSULE AND DELIVERY SYSTEM 9012B1011 (5-PACK) AND 9012B1001 (SINGLE-PACK) FIELD ACTION - FAILURE TO DETACH, PHYSICIAN COMMUNICATION (03-DECEMBER-2007).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR, THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. THE HANDLE/PLUNGER BROKE DURING THE PROCEDURE. NO SERIOUS INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q211878

    Patients

    Seq Age Sex Outcome Treatment
    1