BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 63069 · Received January 10, 1997

    Report

    Report Number
    3014398-1997-00002
    Event Type
    Injury
    Date Received
    January 10, 1997
    Date of Event
    December 12, 1996
    Report Date
    December 12, 1996
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES OF IRELAND, LTD.
    Product Code
    MGB
    Removal / Correction Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMOVED THROMBUS WAS EXAMINED FOLLOWING THE THROMBECTOMY PROCEDURE. THE ANCHOR WAS NOT DETERMINED TO BE LOCATED WITHIN THE THROMBUS, INDICATING THAT THE THROMBOTIC EPISODE WAS NOT DEVICE RELATED, BUT RATHER A CLINICAL EVENT. PLEASE NOTE THAT 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 CORONARY PROCEDURE, AN ANGIO-SEAL DEVICE WAS USED TO SUCCESSFULLY ACHIEVE HEMOSTASIS IN THE PATIENT. TWO DAYS FOLLOWING DEVICE DEPLOYMENT, THE PATIENT EXPERIENCED VESSEL OCCLUSION DUE TO A THROMBUS AT THE ARTERIAL PUNCTURE SITE. A THROMBECTOMY PROCEDURE WAS SUBSEQUENTLY PERFORMED. THE PATIENT WAS DOING WELL AS OF 3/25/97, WITH NO SEQUELAE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention