BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 129014 · Received October 27, 1997

    Report

    Report Number
    3014398-1997-00154
    Event Type
    Malfunction
    Date Received
    October 27, 1997
    Date of Event
    September 24, 1997
    Report Date
    September 25, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE ON 09/24/1997, AN ANGIO-SEAL DEVICE WAS PLACED. EIGHT HRS POST DEPLOYMENT (AND TWO HRS POST AMBULATION), THE PT DEVELOPED A LARGE HAMATOMA. A PRESSURE DRESSING AND A SANDBAG WERE APPLIED. A DOPPLER WAS PERFORMED WHICH REVEALED NO PSEUDOANEURYSM, ALTHOUGH VISIBLE PLAQUE IN THE ILIAC WAS SEEN. THE NEXT DAY (09/25/1997) THE HEMATOMA HAD RESOLVED, THE PT HAD GOOD PULSES, AND NO FURTHER PROBLEMS WERE REPORTED. ON 09/30/1997 THE PT RETURNED TO THE HOSP WITH A HEMATOMA. THE PT HAD VASCULAR REPAIR AND EVACUATION OF THE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 800807

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR