BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASH ADVANTAGE CATHETER

    MDR report key: 885816 · Received July 25, 2007

    Report

    Report Number
    1450420-2007-00001
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    May 23, 2007
    Report Date
    July 10, 2007
    Manufacturer
    MEDIGROUP INC.
    Product Code
    FJS
    PMA / PMN Number
    K991042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY OF THIS PRODUCT INDICATES THAT THIS IS THE FIRST COMPLAINT FOR THIS PRODUCT AND DEFECT MODE SINCE THE PRODUCT'S INTRODUCTION IN THE MARKETPLACE IN 1999. BASED ON THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, THERE IS NO INDICATION THAT THIS MANUFACTURING LOT NUMBER IS SUSPECT OR MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE COMPLAINT HISTORY REVIEW, THERE IS NO EVIDENCE OF AN EMERGING TREND OF DEFECTS FOR THIS PRODUCT. THIS COMPLAINT WILL BE RECORDED AND USED FOR TRACKING AND TRENDING PURPOSES. HOWEVER, IT APPEARS THAT THIS IS AN UNUSUAL, ONE-TIME OCCURRENCE.

    Description of Event or Problem · 1

    PHYSICIAN INTRODUCED A PERITONEAL DIALYSIS CATHETER INTO THE PATIENT USING A QUILL ASSEMBLY, A STAINLESS-STEEL KEY TUBE AND A PLASTIC RED GUIDE. AS HE WAS REMOVING THE RED GUIDE (PER NORMAL), THE TAB BROKE OFF FROM THE RED GUIDE. HE USED A HEMOSTAT TO PULL OUT THE REST OF THE RED GUIDE, AND THE RED GUIDE BROKE INTO TWO PIECES, BOTH OF WHICH WERE REMOVED WITH THE HEMOSTAT. THE PHYSICIAN FINISHED IMPLANTING THE CATHETER, TESTED THE CATHETER, AND CLOSED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASH ADVANTAGE CATHETER FJS PERITONEAL DIALYSIS CATHETER FJS MEDIGROUP INC. CA-5370 V-3246

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention