BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2800022 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06637
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICES WERE DISCARDED AT THE FACILITY; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HANDLING DATABASE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF COMMON FEMORAL ARTERIES WAS ATTEMPTED USING STARCLOSE SE DEVICES AFTER INTERVENTIONAL PROCEDURES. REPORTEDLY, ADVANCEMENT OF THE THUMB ADVANCER WAS HARD TO FINISH. IN SOME CASES FORCE WAS USED TO PRESS THE THUMB ADVANCER ALL THE WAY DOWN. IN SOME CASES HEMOSTASIS WAS ACHIEVED WITH THE DEVICE AND IN OTHER CASES THE STARCLOSE SE WAS REMOVED FROM THE PATIENT AFTER USING THE ACCESS PORTS. IN THESE CASES ANOTHER STARCLOSE SE WAS USED SUCCESSFULLY TO CLOSE THE PUNCTION SITE. THERE WERE NO ADVERSE PATIENT SEQUELAE. THE PHYSICIANS ARE REPORTED TO BE TRAINED AND EXPERIENCED USERS IN THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 5 FR COOK