BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK PTA DILATATION CATHETER

    MDR report key: 2941574 · Received February 4, 2013

    Report

    Report Number
    1016427-2013-20001
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THE UF/IMPORTER REPORT # IS (B)(4).

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING AN ANGIOPLASTY PROCEDURE, A 2.5 X 150MM BALLOON BROKE AWAY FROM THE CATHETER IN THE POSTERIOR TIBIAL ARTERY. THE BALLOON WAS FREE ON THE GUIDEWIRE AND WAS RETRIEVED WITH A CATHETER LASSO. NO ADVERSE CONSEQUENCE WAS NOTIFIED. SEVERAL UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47202 SLEEK PTA DILATATION CATHETER PTA CATHETERS LIT CLEARSTREAM TECHNOLOGIES LTD NA 50042782

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R