BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMAX CHRONIC HEMODIALYSIS CATHETER

    MDR report key: 2000052 · Received February 18, 2011

    Report

    Report Number
    1319211-2011-00020
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    PMA / PMN Number
    K080400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE WAS RETAINED BY THE END USER'S RISK MANAGEMENT. HOWEVER, AN INVESTIGATION INTO THE ROOT CAUSE FOR THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    WHILE TUNNELING A DIALYSIS CATHETER, THE PLASTIC TUNNELER SLEEVE SHATTERED AS IT WAS BEING PULLED THROUGH THE TUNNEL TRACK. AN INCISION WAS MADE ALONG THE ENTIRE TUNNEL AND THE SLEEVE FRAGMENTS WERE SUCCESSFULLY REMOVED FROM THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CATHETER. NO FURTHER HARM WAS REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMAX CHRONIC HEMODIALYSIS CATHETER DIALYSIS CATHETER MSD ANGIODYNAMICS NA 527755

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention