BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1022119 · Received March 25, 2008

    Report

    Report Number
    2953144-2008-00203
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EVAL OF THE RETURNED DEVICE REVEALED BENT VESSEL LOCATOR WINGS (VLW), WHICH WERE SECURE IN THEIR ATTACHMENT TO THE VESSEL LOCATOR ASSEMBLY. ALL OTHER INSPECTION POINTS INDICATED A NORMAL DEVICE THAT FUNCTIONED PROPERLY. THE BENT CONDITION OF THE VLW IS CONSISTENT WITH RESISTANCE ENCOUNTERED TO COLLAPSE, USUALLY FROM AN UNK SOURCE, WHICH CREATES A SITUATION WHERE THE VLW DO NOT WITHDRAW INTO THE DELIVERY TUBE NECESSITATING THE USE OF COUNTER FORCE TO REMOVE THE DEVICE FROM THE PT. WE WERE UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE DAMAGED VLW, NO MANUFACTURING ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO REMOVE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE WAS DIFFICULT TO REMOVE. THE PHYSICIAN HELD PRESSURE ON THE ACCESS SITE AND PULL THE DEVICE TO REMOVE IT FROM THE PT'S BODY. THE CLIP ACHIEVED HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L 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 62032-6H

    Patients

    Seq Age Sex Outcome Treatment
    1