BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 76399 · Received March 14, 1997

    Report

    Report Number
    3014398-1997-00017
    Event Type
    Injury
    Date Received
    March 14, 1997
    Report Date
    February 12, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES OF IRELAND, LTD.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY QUINTON INSTRUMENT CO. OR SHERWOOD DAVIS & GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY QUINTON INSTRUMENT CO. OR SHERWOOD DAVIS & GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY, OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE, AN ANGIO-SEAL DEVICE WAS DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERY. DEPLOYMENT SEEMED NORMAL, ALTHOUGH THE PHYSICIAN NOTED PERIPHERAL ARTERIOSCLEROSIS AT THE TIME. MANUAL PRESSURE AND A COMPRESSION BANDAGE WERE USED TO ACHIEVE HEMOSTASIS, AND THE PATIENT WAS KEPT AT THE HOSPITAL FOR OBSERVATION. TWO WEEKS LATER, AFTER ATTEMPTING A SHORT WALK, THE PATIENT EXPERIENCED CLAUDICATION. AN ULTRASOUND SHOWED VESSEL OCCLUSION, AND SURGICAL INTERVENTION WAS REQUIRED. PATIENT IS CURRENTLY DOING WELL, WITH NO SEQULAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB SHERWOOD MEDICAL INDUSTRIES OF IRELAND, LTD. NA 96J231E & 96J251E

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention