BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL 8 FRENCH

    MDR report key: 318906 · Received March 2, 2001

    Report

    Report Number
    2953144-2001-00036
    Event Type
    Injury
    Date Received
    March 2, 2001
    Date of Event
    February 8, 2001
    Report Date
    February 9, 2001
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED CLOSURE OF THE ARTERIOTOMY WITH A PROSTAR PXL-8 FR DEVICE. AT DEPLOYMENT THE NEEDLES BECAME STUCK IN THE BARREL. BACK DOWN WAS ATTEMPTED, BUT WAS NOT SUCCESSFUL. THE PT WAS TAKEN TO SURGERY, WHERE THE DEVICE WAS REMOVED. THE PT WAS DISCHARGED TO HOME THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9112 PROSTAR XL 8 FRENCH PERCUTANEOUS VASCULAR SURGICAL MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R PROCEDURE.| PT WAS ON REOPRO AND HEPARIN AT THE TIME OF THE