BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOSEAL ES

    MDR report key: 324241 · Received April 4, 2001

    Report

    Report Number
    9681824-2001-00041
    Event Type
    Injury
    Date Received
    April 4, 2001
    Date of Event
    March 2, 2001
    Report Date
    March 3, 2001
    Manufacturer
    DATASCOPE CORP./COLLAGEN PRODUCTS
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 03/2001, THE CUSTOMER REPORTED THAT FOUR DAYS POST VASOSEAL ES DEPLOYMENT A PT WAS ADMITTED WITH A GROIN SITE INFECTION AND LATER DEVELOPED ENDOCARDITIS. ON 04/03/2001 DATASCOPE WAS INFORMED THAT CULTURES OF THE PUNCTURE SITE REVEALED STAPH AUREUS AND ANAEROBES AND THE PT WAS DIAGNOSED WITH SEPTICERNIA. ANTIBIOTIC WERE GIVEN AND THE PT LATER DEVELOPED ENDOCARDITIS. THE PT WAS THEN TAKEN FOR AN EMERGENCY AORTIC VALVE REPLACEMENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14762 VASOSEAL ES EXTRAVASCULAR SECURITY DEVICE MGB DATASCOPE CORP./COLLAGEN PRODUCTS NA 06230241

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR ANTIBIOTICS.