BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL 8FR PVS

    MDR report key: 266963 · Received March 1, 2000

    Report

    Report Number
    2953144-2000-00023
    Event Type
    Injury
    Date Received
    March 1, 2000
    Date of Event
    January 24, 2000
    Report Date
    February 1, 2000
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CARDIOLOGIST ATTEMPTED CLOSURE AFTER AN INTERVENTIONAL PROCEDURE WITH A PROSTAR PXL 8FR DEVICE. THE DEVICE WAS INSERTED AND GOOD MARKING WAS OBTAINED. THE PHYSICIAN REPORTS OF NOT ENCOUNTERING RESISTANCE AS PHYSICIAN PULLED ON THE HANDLE. THREE OF THE 4 NEEDLES PRESENTED IN THE HUB. NEEDLE BACKDOWN WAS PERFORMED. FLUOROSCOPY WAS NOT PERFORMED AT THIS TIME TO CONFIRM THAT NEEDLE BACKDOWN WAS SUCCESSFUL. THE DEVICE WAS RE-DEPLOYED, AND RESISTANCE WAS ENCOUNTERED. THE HANDLE OF THE DEVICE COULD ONLY BE MOVED OVER A SMALL RANGE. FLUOROSCOPY WAS PERFORMED, CONFIRMING THAT 1 NEEDLE WAS BENT INSIDE THE VESSEL, AND 3 NEEDLES WERE IN THE BARREL. THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE DEVICE. THE PT RECOVERED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL 8FR PVS PERCUTANEOUS VASCULAR SURGICAL MGB PERCLOSE, INC. NA 5467

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention NONE REPORTED.