BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1842368 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01989
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    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
    MO, 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 NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED FOR THE REPORTED DEVICE EVENT. THREE STERILE REPRESENTATIVE SAMPLES WITH LOT# 69033-6H WERE RETURNED FOR EVAL. ALL THREE 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 DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER UNEVENTFUL CLIP DEPLOYMENT BLEEDING CONTINUED. ADJUNCTIVE COMPRESSION WAS APPLIED FOR "2 TO 3 MINUTES" TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention