BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL 8 FRENCH

    MDR report key: 274400 · Received April 18, 2000

    Report

    Report Number
    2953144-2000-00060
    Event Type
    Injury
    Date Received
    April 18, 2000
    Date of Event
    March 30, 2000
    Report Date
    March 30, 2000
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN INTERVENTIONAL PROCEDURE. THE PHYSICIAN ATTEMPTED CLOSURE OF THE ARTERIOTOMY WITH A PROSTAR PXL 8 FR. DEVICE. WHEN ATTEMPTING TO DEPLOY THE NEEDLES, RESISTANCE WAS ENCOUNTERED. NEEDLE BACKDOWN WAS SUCCESSFUL, AND THE FIRST DEVICE WAS EXCHANGED FOR A SECOND. RESISTANCE WAS AGAIN ENCOUNTERED WHEN NEEDLE DEPLOYMENT WAS ATTEMPTED. INITIAL BACKDOWN ATTEMPT WAS UNSUCCESSFUL. UNDER FLUORO THE NEEDLES WERE VISUALIZED HALF DEPLOYED IN THE BARREL OF THE DEVICE. WITH SOME MANIPULATION, THE NEEDLES WERE BACKED DOWN FAR ENOUGH TO REMOVE THE DEVICE. MANUAL COMPRESSION WAS USED TO ACHIEVE CLOSURE. THE PT RECOVERED WITHOUT INCIDENT. THE SURGICAL CLIPS WERE VISUALIZED WHEN FLUOROSCOPY WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL 8 FRENCH PERCUTANEOUS VASCULAR SURGICAL MGB PERCLOSE, INC. NA 603666H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention PT WAS RECEIVING HEPARIN.