BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1161288 · Received September 15, 2008

    Report

    Report Number
    2953144-2008-01485
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE IS BEING HELD BY THE USER FACILITY RISK MANAGEMENT. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (AGAINST IFU) THE STARCLOSE INSTRUCTIONS FOR USE STATE, "DO NOT USE THE STARCLOSE VASCULAR CLOSURE SYSTEM IF THE PUNCTURE SITE IS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY OR THE PROFUNDA FEMORIS ARTERY, SUCH PUNCTURE SITES MAY RESULT IN A PSEUDOANEURYSM, INTIMAL DISSECTION, OR AN ACUTE VESSEL CLOSURE (THROMBOSIS OF THE SMALL LUMEN.)" ADDITIONALLY, "DO NOT ADVANCE THE THUMB ADVANCER AGAINST EXCESSIVE FORCE. IF EXCESSIVE FORCE IS EXPERIENCED WHILE ADVANCING THE THUMB ADVANCER, IT MAY BE DUE TO THE CLIP DELIVERY TUBE CARVING INTO THE NYLON SHAFT."

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: THUMB ADVANCER RESISTANCE, DETACHED VESSEL LOCATOR ASSEMBLY. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: SURGICAL REMOVAL AND HEMOSTASIS. IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE PROFUNDA FEMORIS ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING STEP 3 (SHEATH SPLITTING) THE THUMB ADVANCER STROKE, EXCESSIVE RESISTANCE WAS FELT. AFTER CLIP DEPLOYMENT THE DISTAL PORTION OF THE NYLON SHAFT, WIRE CONTROLLER AND COMPLETE VESSEL LOCATOR WING ASSEMBLY DETACHED IN THE VESSEL. THE WIRE CONTROLLER PROTRUDED THROUGH THE CENTER OF THE CLIP BUT THE CLIP STILL ACHIEVED HEMOSTASIS. THE DETACHED DEVICE PARTS AND THE CLIP WERE SURGICALLY REMOVED. THE ARTERY WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. THE PATIENT WAS DISCHARGED THE NEXT DAY AS PLANNED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 58 YR Required Intervention INTEGRILIN