BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 10335783 · Received July 28, 2020

    Report

    Report Number
    3009211636-2020-00160
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    March 31, 2015
    Report Date
    July 28, 2020
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: A RETROSPECTIVE STUDY OF PALINDROME SYMMETRICAL-TIP CATHETERS FOR CHRONIC HEMODIALYSIS ACCESS IN (B)(6); SOURCE: REN FAIL, VOLUME 37, 2015 (941-946) ARTICLE NUMBER: 6 DATE OF PUBLICATION ONLINE: 6 MAY 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MAY 2009 AND DECEMBER 2011, A RETROSPECTIVE STUDY OF 284 CASES OF CHRONIC CATHETERIZATION IN 271 PATIENTS TREATED USING SYMMETRICAL-TIP (N¼118) AND/OR STEP-TIP (N¼166) HEMODIALYSIS CATHETERS WAS CONDUCTED TO EVALUATE THE EFFICACY AND THE SAFETY OF SYMMETRICAL-TIP DIALYSIS CATHETERS FOR CHRONIC HEMODIALYSIS, COMPARED WITH A STEP-TIP CATHETER. OF THESE CATHETERIZATIONS, 118 WERE PERFORMED USING 36/40 CM PRE-CURVED OR STRAIGHT SYMMETRICAL-TIP CATHETERS INCLUDING 14 CASES WHERE STEP-TIP CATHETERS WERE CHANGED TO SYMMETRICAL-TIP, AND 166 CATHETERIZATIONS WERE PERFORMED USING 36/40 CM STEP-TIP CATHETERS. IT WAS STATED THAT DURING THE STUDY PERIOD OF USING SYMMETRICAL-TIP HEMODIALYSIS CATHETERS, THERE WERE 44 CASES OF LOW BLOOD FLOW WITH OCCURRENCE RATE OF 1.13 (RATES WERE CALCULATED AS A NUMBER OF EVENTS PER 1000 CATHETER DAYS); THREE OF THESE CASES REQUIRED CATHETER WITHDRAWALS (INCLUDING ABNORMAL POSITION DYSFUNCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800206 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR