BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL CATHETER

    MDR report key: 6479906 · Received April 11, 2017

    Report

    Report Number
    6479906
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 23, 2017
    Report Date
    March 27, 2017
    Manufacturer
    BIO2 MEDICAL INC.
    Product Code
    PNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED WITH SPINE, CLAVICLE, RIB, AND SCAPULA FRACTURES AFTER BEING THROWN FROM A HORSE. FOUR DAYS AFTER THEY WERE ADMITTED, DURING AN ANGEL CATHETER REMOVAL IN IR, THE CATHETER BROKE INTO PIECES INSIDE THE PATIENT. METAL SHARDS WERE REMOVED AND SENT TO PATHOLOGY. A CT WAS COMPLETED AND NEGATIVE FOR ANY FOREIGN BODIES. MANUFACTURER RESPONSE FOR ANGEL CATHETER, (BRAND NOT PROVIDED) (PER SITE REPORTER): UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262677 ANGEL CATHETER SHORT-TERM INTRAVASCULAR FILTER CATHETER PNS BIO2 MEDICAL INC. AC3930A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR