BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UP OVER BALKIN CONTRALATERAL CHECK FLO PERFORMER INTRODUCE

    MDR report key: 660120 · Received November 30, 2005

    Report

    Report Number
    660120
    Event Type
    Malfunction
    Date Received
    November 30, 2005
    Date of Event
    November 14, 2005
    Report Date
    November 28, 2005
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PERFORMING ANGIOPLASTY ON LOWER EXTREMITY, FOLLOWING CHECK ANGIOGRAM THE UP AND OVER SHEATH BROKE OFF THE HUB BECOMING DISLODGED IN THE PATIENT. AN ADDITIONAL PUNCTURE WAS MADE ON THE OPPOSING SIDE AND A SNARE WAS UTILIZED TO RETRIEVE AND REMOVE THE SHEATH. FOLLOW UP REVEALS THAT WITHIN 48 HOURS, THE PATIENT DEVELPOED A SMALL PSEUDOANEURYSM THOUGHT TO BE ASSOCIATED WITH THE BROKEN SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UP OVER BALKIN CONTRALATERAL CHECK FLO PERFORMER INTRODUCE INTRODUCER SHEATH WITHOUT WIRE GUIDE DYB COOK INCORPORATED RCFW-6.0-38-40-RB-BLKN 1556876 OR 1457827

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR