BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS

    MDR report key: 507672 · Received January 23, 2004

    Report

    Report Number
    2182269-2004-00009
    Event Type
    Injury
    Date Received
    January 23, 2004
    Date of Event
    December 17, 2003
    Report Date
    January 23, 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 FOLLOWING AN ILIAC ANGIOPLASTY AND PRE-DEPLOYMENT ANGIOGRAM, AN ANGIO-SEAL DEVICE WAS SUCCESSFULLY DEPLOYED TO SEAL THE ARTERIOTOMY SITE. THE PATIENT DEVELOPED SYMPTOMS OF A RETROPERITONEAL HEMATOMA. AN EXPLORATORY LAPAROTOMY VIA A MIDLINE INCISION REVEALED A RIGHT FLANK EXTRA PERITONEAL HEMATOMA AND A SMALL HOLE IN THE COMMON FEMORAL ARTERY. THE ARTERY WAS REPAIRED WITH A SINGLE SUTURE AND A REDIVAC LINE WAS PLACED TO EVACUATE THE HEMATOMA. THE ANGIO-SEAL DEVICE COULD NOT BE LOCATED. THE PHYSICIAN STATED THE ARTERIOTOMY SITE MAY HAVE BEEN HIGH. THE EVENT OCCURRED DURING AN ANGIO-SEAL STS UPGRADE; THE ST. JUDE MEDICAL REPRESENTATIVE WAS PRESENT. THE PATIENT WAS REPORTEDLY RECOVERING AND HAD BEEN DISCHARGED TO HOME.

    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 03DK45

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention