BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 2232244 · Received August 25, 2011

    Report

    Report Number
    MW5021931
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DURING LEFT HEART CATHETERIZATION ANGIO SEAL VASCULAR CLOSURE DEVICE PRODUCED BY ST. JUDE MEDICAL SERIAL NUMBER (B)(4) LOT 3354299 BROKE OFF INSIDE THE PT'S ARTERY. SUBSEQUENT ATTEMPTS TO REMOVE THE BROKEN PART HAVE BEEN UNSUCCESSFUL. PT'S ARTERY IS NOW BLOCKED BY THIS BROKEN DEVICE. BY-PASS SURGERY WAS CONSIDERED BUT PT HAS BEEN TOLD IT WILL DO MORE HARM THAN GOOD. EVENT OCCURRED (B)(6) 2011 AT (B)(6) HOSP IN (B)(6). THE BROKEN DEVICE REMAINS IN PLACE. ATTENDING PHYSICIAN WAS (B)(6) MD MEDICAL RECORD NUMBER IS (B)(6). HOSPITAL HAS SUPPOSEDLY REPORTED THIS EVENT AND FDA IS SUPPOSEDLY INVESTIGATING. MFR HAS ALSO SUPPOSEDLY BEEN NOTIFIED AND IS SUPPOSEDLY INVESTIGATING. PT IS EXTREMELY CONCERNED ABOUT HIS HEALTH AND LONG TERM OUTCOME. PT DESIRES THAT THIS BROKEN DEVICE BE SAVED FOR INSPECTION AND TESTING BY THE FDA AND OTHERS TO DETERMINE THE CAUSE OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO SEAL VASCULAR CLOSURE DEVICE ANGIO SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL 3354299

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R| S