BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1832342 · Received September 3, 2010

    Report

    Report Number
    2953144-2010-01836
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    May 1, 2010
    Report Date
    August 18, 2010
    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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED, THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO SPLIT THE SHEATH. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENTS: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE EXCHANGE SHEATH WAS BULKY, THE MATERIAL WAS "TOO" THICK AND THE SHEATH WAS DIFFICULT TO SPLIT. IT WAS REPORTEDLY HARD TO GET TACTILE FEEL DURING SPLITTING OF THE SHEATH. THE PHYSICIAN REPORTED THAT THIS HAS OCCURRED FROM (B)(6)2010 TO (B)(6)2010 IN APPROXIMATELY 85% OF HIS PROCEDURES. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE OR PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 87048-6H

    Patients

    Seq Age Sex Outcome Treatment
    1