BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851518 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02076
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    October 16, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE CUSTOMER REPORTED THE STARCLOSE SE DEVICE USED IN THE CLOSURE PROCEDURE WAS DISCARDED; HOWEVER, THE LOT NUMBER WAS PROVIDED. TEN UNUSED REP SAMPLES WITH THE SAME PART AND LOT NUMBER AS THE COMPLAINT DEVICE WERE RETURNED FOR EVAL. ALL TEN DEVICES PASSED FUNCTIONAL TESTING WITHIN SPECIFICATION. NO MALFUNCTION OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE COMPLAINT DEVICE REPORTED EXPERIENCE COULD NOT BE DETERMINED, BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE WAS DIFFICULT TO REMOVE. THE PHYSICIAN WAS UNAWARE OF THE NEW SAFETY RELEASE MECHANISM AND USED COUNTER-TRACTION AND AGGRESSIVELY PULLED TO REMOVE THE DEVICE. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 68170-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention