BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK RX PTA DILATATION CATHETER

    MDR report key: 2926176 · Received January 14, 2013

    Report

    Report Number
    9616666-2013-00001
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BROKE AWAY FROM THE CATHETER. THE REPORTED FAILURE OCCURRED DURING AN ANGIOPLASTY PROCEDURE. REPORTEDLY, THE BALLOON DETACHED IN THE POSTERIOR TIBIAL ARTERY. THE BALLOON WAS FREE ON THE GUIDEWIRE AND WAS REMOVED USING A CATHETER LASSO. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21253 SLEEK RX PTA DILATATION CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50042782

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention