BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 809577 · Received January 23, 2007

    Report

    Report Number
    2953144-2007-00044
    Event Type
    Other
    Date Received
    January 23, 2007
    Date of Event
    January 4, 2007
    Report Date
    January 5, 2007
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    FZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THERE WAS NO LOT INFORMATION. WE WERE NOT ABLE TO PERFORM DEVICE INSPECTION OR DEVICE HISTORY RECORD REVIEW IN THIS CASE.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY CLOSED AN ARTERIOTOMY SITE WITH THE STARCLOSE DEVICE FOLLOWING A DIAGNOSTIC PROCEDURE. THERE WAS SOME OOZING AND 30 MINUTES POST PROCEDURE, A HEMATOMA WAS OBSERVED WHICH GREW TO 17X20 CM. A CT SCAN WAS OBTAINED. IT WAS NEGATIVE FOR A RETROPERITONEAL BLEED, BUT THE PATIENT WAS DIAGNOSED WITH A RIGHT GROIN BLEED. THE PATIENT WAS SENT TO ICU. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM FZP ABBOTT VASCULAR INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| O