BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIGHOST

    MDR report key: 2013460 · Received March 4, 2011

    Report

    Report Number
    MW5019689
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    B. BRAUN MEDICAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING FEMORAL ANGIO, DR. (B)(6) PLACED A B. BRAUN MINI-GHOST BALLOON THROUGH A CONTRALATERAL SHEATH AND INTO RIGHT SFA. THE WIRE WAS REMOVED FOR A CONTRAST INJECTION. FOLLOWING THE INJECTION, SEVERAL ATTEMPTS WERE MADE TO INTRODUCE A WIRE INTO THE MINIGHOST USING SEVERAL DIFFERENT SIZE & BRANDS OF WIRES. NOTHING WOULD ADVANCE FURTHER THAN 10-15CM. DR. STATED THAT IT FELT LIKE THE WIRE HUNG UP ON A "LEDGE." EVENTUALLY, THE CATHETER WAS CUT, A WIRE ADVANCED THROUGH THE LUMEN AND THE MINI-GHOST EXCHANGED FOR AN EV3 POWERCROSS. PTA PERFORMED, FOLLOWED BY STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIGHOST ANGIOPLASTY BALLOON DQY B. BRAUN MEDICAL 612690 MG-1489

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR