BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS

    MDR report key: 541947 · Received September 2, 2004

    Report

    Report Number
    2182269-2004-00157
    Event Type
    Injury
    Date Received
    September 2, 2004
    Date of Event
    August 11, 2004
    Report Date
    September 2, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A DIAGNOSITC CARDIAC CATHETERIZATION, A 6F ANGIO-SEAL STS WAS DEPLOYED SUCCESSFULLY WITH INSTANT HEMOSTASIS ACHIEVED. LATER THAT DAY, THE PT DEVELOPED A COLD LEG WITH SYMPTOMS OF DIMINISHED CIRCULATION AND WAS SCHEDULED TO HAVE A FEMORAL ANGIOGRAM AT ANOTHER HOSPITAL THE NEXT DAY. THE ST. JUDE MEDICAL REPRESENTATIVE WAS PRESENT DURING THE ANGIOGRAM WHICH REVEALED AN OBSTRUCTION AT THE LEVEL WHERE THE ANGI0-SEAL WAS DEPLOYED. THE PHYSICIAN STATED A CLOT MAY HAVE BEEN THE CAUSE OF THE OBSTRUCTION. REPORTEDLY, THE PT UNDERWENT SURGERY. THE INITIAL PRE-DEPLOYMENT FEMORAL ANGIOGRAM WAS REVIEWED WITH THE ST. JUDE MEDICAL REPRESENTATIVE AND IT WAS NOTED THE REQUIRED PRE-DEPLOYMENT CRITERIA OF VESSEL SIZE, ABSENCE OF PLAQUE, AND THE LOCATION OF PUNCTURE IN COMMON FEMORAL ARTERY WERE MET. THE PHYSICIAN STATED THE PT HAD KNOWN ALLERGIES SO THEY WEREN'T ON ANTI-COAGULANT THERAPY; THEREFORE THEIR MEDICAL CONDITION WAS PRONE TO THROMBUS FORMATION. A SEARCH OF THE DATABASE REVEALED NO CERTIFICATION DOCUMENTATION FOR THIS USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS 6F ANGIO-SEAL STS MGB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention