BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1133168 · Received August 22, 2008

    Report

    Report Number
    2953144-2008-01387
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 30, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF MALFUNCTION: AFTER VESSEL CLOSURE. SYMPTOMS/AE: ACCESS SITE PAIN. DIMINISHED LEG PULSES, OCCLUSION. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, FORTH-EIGHT HOURS AFTER UNEVENTFUL VESSEL CLOSURE, THE PT DEVELOPED SYMPTOMS OF PAIN AT THE CLOSURE SITE AND DIMINISHED PULSES OF THE LEG. EXPLORATORY SURGERY REVEALED AN OCCLUSION AT THE CLOSURE SITE DUE TO CALCIFIED PLAQUE. THE STARCLOSE CLIP WAS SURGICALLY REMOVED AND THE ARTERY WAS SURGICALLY REPAIRED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention