BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 118630 · Received September 8, 1997

    Report

    Report Number
    3014398-1997-00104
    Event Type
    Malfunction
    Date Received
    September 8, 1997
    Date of Event
    July 18, 1997
    Report Date
    August 6, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT HAD A PTCA PROCEDURE IN THE AM, FOLLOWING WHICH SHE REMAINED ON BED REST WITH THE SHEATHS IN PLACE (A DISSECTION OF THE RCA RESULTED IN THE PROCEDURE BEING TERMINATED EARLY). AT 6:00 PM AN ANGIO-SEAL DEVICE WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. HOWEVER, 3.5 HRS LATER AS THE PT WAS AMBULATING, BLEEDING OCCURRED, AND APPROX 1-2 UNITS OF BLOOD WERE LOST. THE PT WAS RETURNED TO BED. HEMOSTASIS WAS ACHIEVED USING CONVENTIONAL METHODS, AND THE PT WAS DISCHARGED HOME THE FOLLOWING DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO