BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE CORP/COLLAGEN PRODUCTS DIV

    MDR report key: 620564 · Received June 30, 2005

    Report

    Report Number
    2249677-2005-00011
    Event Type
    Malfunction
    Date Received
    June 30, 2005
    Date of Event
    April 8, 2005
    Report Date
    May 18, 2005
    Manufacturer
    DATASCOPE CORP./COLLAGEN PRODUCTS DIV.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA MEDWATCH THAT A PT UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE IN 2005. POST CATHETERIZATION THE PT COMPLAINED OF PAIN AT THE GROIN INSERTION SITE. EXPLORATION OF THE GROIN REVEALED A J WIRE FRAGMENT. NO ONE HAD NOTED IT AT THE TIME OF THE CATHETERIZATION PROCEDURE AND AFTER DEPLOYMENT OF VASOSEAL ES THAT THE J WIRE WAS NOT INTACT SINCE IT WAS NORMALLY INSIDE THE SHEATH AND NOT VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE CORP/COLLAGEN PRODUCTS DIV VASCULAR HEMOSTASIS DEVICE MGB DATASCOPE CORP./COLLAGEN PRODUCTS DIV. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1