BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 76239 · Received March 14, 1997

    Report

    Report Number
    3014398-1997-00019
    Event Type
    Injury
    Date Received
    March 14, 1997
    Date of Event
    November 28, 1996
    Report Date
    February 12, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES OF IRELAND, LTD.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY REPORTED DUE TO INSUFFICIENT INFO. THIS EVENT DID NOT INVOLVE A SERIOUS INJURY, NOR WAS INTERVENTION REQUIRED OR PERFORMED. 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

    AN ANGIO-SEAL DEVICE WAS USED FOLLOWING AN UNSUCCESSFUL RECANALIZATION OF THE RIGHT CORONARY ARTERY, AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITHOUT DIFFICULTY. SEVEN DAYS LATER, THE PATIENT COMPLAINED OF PAIN IN THE RIGHT GROIN. ON PHYSICAL EXAM, THE FOOT WAS COOL. AN ULTRASOUND WAS PERFORMED, WHICH SHOWED DECREASED, BUT NOT OBSTRUCTED FLOW, TO THE LOWER LIMB. THE ANCHOR WAS NOT VISUALIZED. NO TREATMENT WAS INITIATED. SYMPTOMS RESOLVED AND THE PATIENT WAS FOLLOWED WITH ULTRASOUND AND FLOW RETURNED TO NORMAL OVER THE NEXT SIX WEEKS. THE PATIENT IS CURRENTLY DOING WELL 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