BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKATER LOCK CATH SET-8FR X 40CM

    MDR report key: 4173246 · Received September 23, 2014

    Report

    Report Number
    1625425-2014-00030
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    March 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FGE
    PMA / PMN Number
    K073672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS MANUFACTURE IN 10/2013 BY (B)(4) WHICH HAS BEEN ACQUIRED BY ARGON MEDICAL DEVICES INC. NO DISCREPANCIES WERE NOTED IN THE DEVICE HISTORY RECORD FOR THE COMPLAINT LOT. THERE ARE NO OTHER. AFTER REVIEWING DEVICES IMAGES AND EXAMINING THE RETURNED DEVICE, IT WAS CONFIRMED THAT THE CATHETER DISCONNECTED AT THE RO BAND. A HEALTH HAZARD EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT NO ADDITIONAL FSC ACTIVITY WAS REQUIRED. THE HEALTH HAZARD ANALYSIS RATED THE RISK OF THIS EVENT TO BE LOW AND NO FSCA IS REQUIRED. A MANUFACTURING CAPA WAS INITIATED ON 11/25/2013 TO MAXIMIZE RO BAN BONDING STRENGTH. THE LOT WAS RO BONDED IN (B)(4) 2013 BEFORE IMPLEMENTATION OF THE CAPA. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR PRODUCT MANUFACTURED AFTER THE ENGINEERING CHANGE WAS IMPLEMENTED. ARGON CONTINUE TO DO THE PULL TESTING AND VISUAL INSPECTION ON CURRENT PRODUCT.

    Description of Event or Problem · 1

    THE DRAINAGE BROKE INSIDE THE PT (BEFORE STARTING THE RETRIEVAL PROCEDURE) AT THE RADIOPAQUE MARKER. AFTER THE IMAGE, AN ATRIEVE SNARE WAS USED TO CAPTURE THE TWO CATH PORTIONS. THE DEVICE WAS PLACED (B)(6) 2014 AND THE BREAK WAS OBSERVED ON (B)(6) 2014 (11 DAYS LATER) AT THE SECOND CHECKUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591035 SKATER LOCK CATH SET-8FR X 40CM BILIARY DRAINAGE CATHETERS FGE ARGON MEDICAL DEVICES INC. 33232L3A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention