BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSEAL

    MDR report key: 9686701 · Received February 7, 2020

    Report

    Report Number
    MW5092859
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 5, 2020
    Manufacturer
    TERUMO INTERVENTIONAL SYSTEMS / TERUMO MEDICAL CORP.
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CARDIAC CATH WITH INTERVENTION. AFTER PROCEDURE ANGIO SEAL WAS USED TO PREVENT BLEEDING FROM RIGHT FEMORAL ARTERY STICK. WHEN PT MET CRITERIA TO GET OOB, PT COMPLAINED OF RIGHT LEG PAIN AND RIGHT FOOT NUMBNESS. NURSE EXAMINED PT AND COULD NOT PALPATE OR DOPLER PULSE. CARDIOLOGIST NOTIFIED AND CONSULTED VASCULAR SURGEON. PT SEEN BY VASCULAR SURGEON AND IMMEDIATELY TAKEN TO THE OPERATING ROOM. PT UNDERWENT THE FOLLOWING SURGERY. RIGHT FEMORAL ARTERY EXPLORATION, THROMBECTOMY OF RIGHT COMMON FEMORAL ARTERY, EXTRACTION OF FOREIGN BODY, REPAIR OF RIGHT COMMON FEMORAL ARTERY, SAPHENOUS VEIN PATCH ANGIOPLASTY OF THE RIGHT COMMON FEMORAL ARTERY, INTRAOPERATIVE ARTERIOGRAM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147703 ANGIOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO INTERVENTIONAL SYSTEMS / TERUMO MEDICAL CORP. 06099970

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R