BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 818636 · Received January 31, 2007

    Report

    Report Number
    2953144-2007-00054
    Event Type
    Other
    Date Received
    January 31, 2007
    Date of Event
    January 11, 2007
    Report Date
    January 11, 2007
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    FZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED, HOWEVER, THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED CLOSURE OF AN ARTERIOTOMY SITE WITH THE STARCLOSE DEVICE FOLLOWING A DIAGNOSTIC PROCEDURE. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE DISTAL END OF THE VESSEL LOCATOR BAND WAS MISSING. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. A VASCULAR SURGEON WAS CONSULTED AND A DECISION WAS MADE TO LEAVE THE CLIP AND DISTAL END OF THE VESSEL LOCATOR BAND IN THE PT. REPORTEDLY, THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM FZP ABBOTT VASCULAR INC. NA 44098-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other