BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 99247 · Received June 18, 1997

    Report

    Report Number
    3014398-1997-00029
    Event Type
    Injury
    Date Received
    June 18, 1997
    Date of Event
    April 5, 1997
    Report Date
    May 20, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED WITH THE DEVICE, AND MANUAL COMPRESSION AND A PRESSURE BANDAGE WERE REQUIRED. HEMOSTASIS WAS THEN ACHIEVED, AND THE PT WAS AMBULATED THE FOLLOWING DAY AFTER 20 HOURS. THE PT COMPLAINED OF SUDDEN PAIN, AND BLEEDING WAS NOTED FROM THE PUNCTURE SITE. UPON EXAM, NO DISTAL PULSES WERE PALPABLE. A DUPLEX ULTRASOUND VISUALIZED THE ANCHOR WITH ATTACHED SUTURE, WHICH HAD EMBOLIZED AND WAS POSITIONED AT THE BIFURCATION OF THE POPLITEAL ARTERY. THE POSTERIOR TIBIAL ARTERY AND THE FIBULAR ARTERY WERE OCCLUDED. CONSERVATIVE TREATMENT WITH ANTICOAGULANTS AND FULL HEPARINIZATION WAS ADMINISTERED (COLLATERAL FLOW WAS SUFFICIENT TO MAINTAIN TISSUE PERFUSION). FOUR DAYS LATER, PULSES HAD RETURNED AND THE FOOT WAS PINK AND WARM. THE PT WAS DISCHARGED WITH NO SEQUELAE, AND AS OF 6/12/97 REMAINS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB SHERWOOD MEDICAL INDUSTRIES NA 97A281E

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention