BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK

    MDR report key: 2479369 · Received February 24, 2012

    Report

    Report Number
    9616666-2012-00004
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    January 19, 2012
    Report Date
    February 23, 2012
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS REMOVED IN THE STERILE FASHION AND PLACED OVER A 0.014" BOSTON SCIENTIFIC FATHOM WIRE TO A TARGET LESION IN THE PERONEAL ARTERY VESSEL. THE BALLOON MARKERS WERE NOT VISIBLE AND THE SCRUB TECH NOTICED THE BALLOON WAS SEPARATED FROM THE SHAFT. THE BALLOON WAS COMPLETELY SEPARATE FROM THE BALLOON CATHETER AND STILL ATTACHED TO THE WIRE MANDREL AND GREEN BALLOON SLEEVE OUTSIDE THE BODY. THE TECH PLACED THE PRODUCT THAT WAS MISSING THE BALLOON INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK PTA BALLOON CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50032364

    Patients

    Seq Age Sex Outcome Treatment
    1