BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK RX PTA DILATATION CATHETER

    MDR report key: 2599035 · Received May 28, 2012

    Report

    Report Number
    9616666-2012-00007
    Event Type
    Injury
    Date Received
    May 28, 2012
    Date of Event
    March 30, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVAL. THE LOT HISTORY RECORD WAS REVIEWED FOR THE PRODUCT, THE LOT MET ALL RELEASE CRITERIA. A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED FROM THE INVESTIGATION. HOWEVER, THE IFU DOES IDENTIFY VESSEL DISSECTION UNDER THE LIST OF KNOWN ADVERSE EVENTS. THE IFU STATES: POSSIBLE ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO VESSEL DISSECTION. NOTE: THIS IS THE SAME PT AND PROCEDURE AS RECORDED IN 96616666-2012-00006. THE PRODUCTS DETAILS ARE DIFFERENT AS TWO PRODUCTS WERE USED IN THE SAME PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) MONTHS AFTER SUCCESSFUL PTA ON THE RIGHT PERONEAL ARTERY, A VESSEL DISSECTION WAS NOTED. REPORTEDLY, THIS WAS TREATED WITH A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK RX PTA DILATATION CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50010083

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention