BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAMAX

    MDR report key: 1719826 · Received May 28, 2010

    Report

    Report Number
    1719826
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 28, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DIALYSIS PATIENT PRESENTED WITH END STAGE RENAL DISEASE, CARDIAC DISEASE AND MULTIPLE MEDICAL ISSUES. SHE HAD MULTIPLE CATHETERS INSERTED AND CHANGED OVER A 15 MONTH PERIOD. LAST MONTH, SHE HAD A CATHETER CHANGE BECAUSE OF A POOR FLOW RATE. AN ANGIODYNAMICS 15.5 FR. 28 DURAMAX CATHETER WAS PLACED. THIS CATHETER WAS NOT FUNCTIONING WELL AND WAS REMOVED TWO DAYS LATER. A KENDALL TAL PALINDROME 14.5 FR CATHETER WAS THEN INSERTED. APPROXIMATELY 3 HOURS LATER, THE PATIENT HAD A PERICARDIAL TAMPONADE AND EXPIRED. AN AUTOPSY REPORT REVEALED A PERFORATION OF THE RIGHT ATRIUM WHICH OCCURRED OVER THE COURSE OF SEVERAL DAYS PRIOR TO THE PATIENT'S DEATH. IT IS NOT KNOWN HOW THE PATIENT SUSTAINED A PERFORATION OF THE RIGHT ATRIUM. SOME POSSIBILITIES ARE: THE CATHETER PLACED (ANGIODYNAMICS 15.5 FR. 28 DURAMAX) RUBBED AGAINST THE RIGHT ATRIUM CAUSING A LOSS OF TISSUE INTEGRITY AT THE SITE OF THE PERFORATION; THE CATHETER TIP IMPINGED UPON THE ATRIAL WALL. OR, THE FIBRIN SHEATH THAT THE BODY NORMALLY PRODUCES AROUND THE CATHETER MAY HAVE BEEN PARTIALLY ATTACHED TO THE RIGHT ATRIUM AND DAMAGED THE TISSUE, ULTIMATELY LEADING TO A PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMAX CATHETER, DIALYSIS MSD ANGIODYNAMICS * 983184
    2 TAL PALINDROME CATHETER, DIALYSIS MSD COVIDIEN * 935530

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death