BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1190305 · Received October 6, 2008

    Report

    Report Number
    2953144-2008-01630
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: CLIP MISLOCATION. SYMPTOMS/AE: CLAUDICATION AND OCCLUSION. TIME OF SYMPTOMS/AE: ONE MONTH POST VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE, ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. APPROXIMATELY ONE MONTH POST PROCEDURE, THE PT WAS EXPERIENCING CLAUDICATION OF THE RIGHT LEG. AN ANGIOGRAM WAS TAKEN AND THE PHYSICIAN FELT THAT THE CLIP HAD CAUGHT THE SIDE ARTERY WALL AND THE ARTERY WAS FOUND TO HAVE AN 80%-90% OCCLUSION. THE LEFT COMMON FEMORAL ARTERY (CONTRALATERAL) WAS ACCESSED TO TREAT THE OCCLUSION IN THE RIGHT COMMON FEMORAL ARTERY. AN UNSPECIFIED BALLOON CATHETER AND STENT WERE USED TO TREAT THE VESSEL. THE PT IS REPORTED TO BE DOING FINE. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    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 69 YR Hospitalization| R