BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 109233 · Received July 29, 1997

    Report

    Report Number
    3014398-1997-00067
    Event Type
    Injury
    Date Received
    July 29, 1997
    Date of Event
    June 24, 1997
    Report Date
    June 30, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIFFICULT INTERVENTIONAL PROCEDURE (IN WHICH STENT PLACEMENT WAS LOST; THE PHYSICIAN BYPASSED THE STENT WITH A BALLOON AND USED THE BALLOON TO COMPRESS THE STENT AGAINST THE WALL OF THE ARTERY), AN ANGIO-SEAL DEVICE WAS PLACED WITHOUT DIFFICULTY. HOWEVER, FOLLOWING DEVICE DEPLOYMENT A SMALL AMOUNT OF OOZING CONTINUED FROM THE SITE, AND LIGHT DIGITAL PRESSURE WAS REQUIRED TO COMPLETE HEMOSTASIS. THE PT WAS TAKEN TO THE FLOOR AND THE SPRING WAS REMOVED AFTER BEING PLACED FOR 35 MINS (IN ACCORDANCE WITH CO'S INSTRUCTIONS FOR USE). TEN MINS LATER, A SMALL AMOUNT OF OOZING WAS NOTED, WHICH AGAIN RESOLVED AFTER 2 MINS OF LIGHT DIGITAL PRESSURE. THE PT WAS RESTLESS AND UNCOMFORTABLE DURING THE NIGHT. THE PT WAS GIVEN A REOPRO INFUSION FOR 12 HRS, DUE TO THE DIFFICULTY OF THE INTERVENTIONAL PROCEDURE. IN THE MORNING, THE PT'S BLOOD PRESSURE WAS NOTED TO HAVE DROPPED; THE PT WAS DIAGNOSED WITH HAVING HAD RETROPERITONEAL BLEEDING DURING THE NIGHT, AND WAS THEN TRANSFUSED WITH TWO UNITS OF WHOLE BLOOD (FOR AN HGB COUNT OF 7.5 GM). THE PHYSICIAN HAS STATED THAT HE FEELS THAT THE EXPERIENCE(S) OF BLEEDING IS LIKELY RELATED TO THE DIFFICULT INTERVENTIONAL PROCEDURE, (HE ALSO STATES THE BLEED WAS COMING FROM TOO HIGH TO BE RELATED TO THE FEMORAL ARTERY SITE) AND WAS NOT CAUSED OR CONTRIBUTED TO BY THE USE OF THE ANGIO-SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB SHERWOOD MEDICAL INDUSTRIES NA 97D091E

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R