BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CATHETER SYSTEM

    MDR report key: 3912214 · Received May 13, 2014

    Report

    Report Number
    3004962788-2014-00031
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K102604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION CONFIRMED THE CUSTOMER'S REPORT THAT THE EXTERIOR OF THE OUTER LINER HAD BEEN SCRAPED BY ANOTHER DEVICE.

    Description of Event or Problem · 1

    THE SITE'S OLYMPUS BRONCHOSCOPE DISTAL END WAS BENT SLIGHTLY AND SCRAPED THE OUTER LINING OF THE EDGE CATHETER AS IT WAS BEING PUSHED THROUGH THE SCOPE. THE PIECES OF THE CATHETER OUTER LINER ENTERED THE PATIENT AND THE PHYSICIAN RETRIEVED THE REMNANTS USING FORCEPS. THE EVENT WAS NOT LIFE THREATENING AND THE PATIENT WAS DISCHARGED SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285556 EDGE CATHETER SYSTEM GUIDE CATHETER JAK SUPERDIMENSION INC. 198-7 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR