BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 705386 · Received April 25, 2006

    Report

    Report Number
    2953144-2006-00080
    Event Type
    Other
    Date Received
    April 25, 2006
    Date of Event
    March 31, 2006
    Report Date
    April 5, 2006
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    FZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN USED A STARCLOSE TO CLOSE AN ARTERIOTOMY IN THE RIGHT COMMON FEMORAL ARTERY (CFA) FOLLOWING A DIAGNOSTIC PROCEDURE. THE PHYSICIAN HELD THE STARCLOSE AT AN 85 DEGREE ANGLE IN ORDER TO COMPLETE THE CLOSURE DUE TO THE DEPTH OF THE ARTERY. THE PT WAS DESCRIBED AS OBSESE AND THE ARTERY WAS 5-6 CM BELOW THE SKIN SURFACE. THE ARTERIOTOMY CLOSURE WAS SUCCESSFUL USING THE STARCLOSE. THE PT RETURNED TO THE HOSP 4 DAYS POST-PROCEDURE COMPLAINAING OF LEG PAIN. THE PT WAS ADMITTED FOR VASCULAR SURGERY FOR A THROMBECTOMY AT THE SITE OF THE CFA CLOSURE. THE THROMBUS WAS DETERMINED BY THE VASCULAR SURGEON TO BE A RESULT OF INTIMAL DAMAGE AT THE SITE OF THE CLOSURE. A VEIN PATCH WAS PLACED AT THE SITE OF THE INTIMAL DAMAGE. THE PT RECOVERED AND WAS DISCHARGED HOME.

    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 42 YR Hospitalization| R