BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1842352 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01964
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    April 29, 2009
    Report Date
    April 30, 2009
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. TWENTY THREE UNUSED REP SAMPLES WITH THE SAME PART NUMBER AS THE COMPLAINT DEVICE AND THREE SEPARATE LOT NUMBERS (73043-6H, 73007-6H, 73053-6H) WERE RETURNED FOR EVAL. FUNCTIONAL TESTING WAS PERFORMED ON ALL OF THE RETURNED DEVICES AND THE DEVICES PASSED FUNCTIONAL TESTING WITHIN PRODUCT SPECS. NO MFG OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE 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 ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER UNEVENTFUL ARTERIOTOMY CLOSURE, TISSUE TRACT BLEEDING OCCURRED UP TO FOUR DAYS AFTER THE PROCEDURE WITH SIX PATIENTS. THE BLEEDING OCCURRED BEFORE AND AFTER THE PATIENTS WERE DISCHARGED. BLEEDING WAS STOPPED WITH A SYVEK TOPICAL PAD AND MANUAL COMPRESSION. THERE WAS REPORTEDLY NO ADVERSE PT SEQUELA. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention