BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 10380457 · Received August 7, 2020

    Report

    Report Number
    3009211636-2020-00182
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    March 31, 2015
    Report Date
    August 7, 2020
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    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 CHINA 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, 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. DURING THE STUDY PERIOD OF USING STEP-TIP HEMODIALYSIS CATHETERS, THERE WERE TWO CASES OF DEATH THAT REQUIRED CATHETER WITHDRAWALS (CATHETERS WERE STILL FUNCTIONAL). THE DEVICE DID NOT CAUSE NOR CONTRIBUTE TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843904 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other