BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOSEAL ES

    MDR report key: 273658 · Received April 12, 2000

    Report

    Report Number
    9681824-2000-00069
    Event Type
    Injury
    Date Received
    April 12, 2000
    Date of Event
    March 15, 2000
    Report Date
    March 20, 2000
    Manufacturer
    DATASCOPE CORP./COLLAGEN PRODUCTS
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FOLLOWING A DIAGNOSTIC CATHETERIZATION IN 2000, A VASOSEAL ES WAS DEPLOYED. DURING DEPLOYMENT, LITTLE OR NO RESISTANCE WAS FELT WHEN THE J SEGMENT OF THE TEMPORARY ARTERIOTOMY LOCATOR WAS ENGAGED. A SECOND ATTEMPTED TO ENGAGE THE J SEGMENT WAS MADE AND RESISTANCE WAS FELT. THE DILATOR WAS ADVANCED AND THEN THE SHEATH. THE J SEGMENT WAS RETRACTED AND THEN THE DIALATOR AND LOCATOR WERE REMOVED. NO RESISTANCE WAS FELT WHEN THE COLLAGEN WAS DEPLOYED. WITHIN FIVE MINS AFTER DEPLOYMENT, THE PT'S LEG WAS MOTTLED AND PULSELESS. THE PT WAS TAKEN TO SURGERY AND A CUT-DOWN OF THE RIGHT FEMORAL ARTERY WITH AN EMBOLECTOMY WAS DONE TO REMOVE COLLAGEN FROM THE ARTERY. A SUTURE/CLOSURE OF THE RIGHT FEMORAL VEIN WAS ALSO PERFORMED. PULSES RETURNED TO THE RIGHT LOWER EXTREMITY. OVER THE NEXT THREE DAYS A TOTAL OF FOUR UNITS OF PACKED RED BLOOD CELLS WERE GIVEN TO TREAT HOW HEMAGLOBIN/HEMATOCRIT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention TRANSFUSED WITH 4 UNITS OF PACKED RED BLOOD CELLS.