BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 512722 · Received February 20, 2004

    Report

    Report Number
    2182269-2004-00027
    Event Type
    Injury
    Date Received
    February 20, 2004
    Date of Event
    January 22, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AN ANGIO-SEAL DEVICE WAS DEPLOYED TO SEAL THE ARTERIOTOMY SITE. THE PHYSICIAN REPORTED RESISTANCE UPON INSERTING THE DEVICE INTO THE SHEATH. AT THE POINT OF ANCHOR DEPLOYMENT, UPON PULLING BACK AND OUT, THE ENTIRE ANGIO-SEAL DEVICE PULLED OUT. MANUAL PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS. APPROXIMATELY ONE HOUR LATER, THE PT COMPLAINED OF ABDOMINAL PAIN AND BECAME HYPOTENSIVE. A CT SCAN CONFIRMED A RETROPERITONEAL HEMATOMA. THE PT WAS REPORTEDLY RECOVERING. THE SURGEON STATED THE RETROPERITONEAL BLEED WAS DUE TO THE PHYSICIAN'S TECHNIQUE AND NOT THE ANGIO-SEAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA 1043276

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention HEPARIN - 2004, DOSAGE UNKNOWN,| PROTAMINE - 2004 DOSAGE UNKNOWN,| ANTICOAGULANTS - DATE, TYPE AND DOSE UNKNOWN.