BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL 8 FR PVS

    MDR report key: 267060 · Received March 1, 2000

    Report

    Report Number
    2953144-2000-00022
    Event Type
    Injury
    Date Received
    March 1, 2000
    Date of Event
    February 1, 2000
    Report Date
    February 1, 2000
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN INTERVENTIONAL PROCEDURE. THE PHYSICIAN ATTEMPTED TO PRECLOSE AN ARTERIOTOMY WITH A PROSTAR PXL 8FR DEVICE. WHEN PHYSICIAN DEPLOYED THE DEVICE, NONE OF THE NEEDLES PRESENTED. THE PHYSICIAN ATTEMPTED TO BACKDOWN, AND PARTIAL BACKDOWN WAS ACHIEVED. PHYSICIAN DID NOT FLUORO TO CONFIRM SUCCESSFUL BACKDOWN, AND REMOVED THE DEVICE. HEMOSTASIS WAS LOST AND COULD NOT BE OBTAINED WITH A 12 FR SHEATH. A VASCULAR SURGEON WAS CALLED IN FOR REPAIR OF THE ARTERIOTOMY. SURGERY WAS SUCCESSFUL, AND THE ORIGINAL INTERVENTIONAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PT RECOVERED WITHOUT INCIDENT. NOTES FROM THE FIELD STATE 2 NEEDLES WERE IN THE BARREL AND 2 IN THE SHEATH OF THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention NONE REPORTED.