BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISH SP DEVICE

    MDR report key: 2153192 · Received June 17, 2011

    Report

    Report Number
    3004534947-2011-00004
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MORRIS INNOVATIVE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P050043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE WAS EXAMINED. ALLEGED FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    USER COULD NOT PROPERLY PLACE FISH, ATTEMPTED TO RETRIEVE DEVICE, REPLACED WITH A 7FR TERUMO SHEATH, DILATOR AND WIRE WERE REMOVED. IT WAS THEN DISCOVERED THAT DISTAL PORTION OF FISH SHEATH TUBING HAD TORN OFF AND WAS INSERTED INTO ILIAC ARTERY. MEDICAL DOCTOR WAS MADE AWARE, FLOW DISTURBANCE WAS WITNESSED UNDER FLUOROSCOPY, MEDICAL DOCTOR DECIDED TO LEAVE IN PLACE UNTIL SUBSEQUENT INTERVENTION PROCEDURE SCHEDULED FOR THE FOLLOWING WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISH SP DEVICE MGB MORRIS INNOVATIVE, INC. 16-06-01-S 4229

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization