BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHSTAR XL 6F

    MDR report key: 272046 · Received March 29, 2000

    Report

    Report Number
    272046
    Event Type
    Injury
    Date Received
    March 29, 2000
    Date of Event
    February 19, 2000
    Report Date
    February 25, 2000
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 2/19/2000 CARDIOVASCULAR LAB REGISTERED NURSE, REPORTED THAT ON 2/19/2000, DR WAS USING THE TECHSTAR XL 6F PERCUTANEOUS VASCULAR CLOSURE DEVICE POST ANGIOPLASTY/STENT PLACEMENT TO CLOSE THE RIGHT FEMORAL ARTERY. ON DELIVERY OF TECHSTAR XL (PERCLOSE) ONE NEEDLE JAMMED INSIDE DELIVERY DEVICE REQUIRING SURGICAL INTERVENTION TO REMOVE DEVICE AND TO CLOSE FEMORAL ARTERY. DEVICE WAS REMOVED, ARTERY CLOSED. PT WAS DISCHARGED 2/21/2000 IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHSTAR XL 6F PERCUTANEOUS VASCULAR CLOSURE DEVICE MGB PERCLOSE, INC. CE 0044 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R PTCA/STENT OF DISTAL RCA.