BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1992145 · Received February 15, 2011

    Report

    Report Number
    2024168-2011-00928
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. ADDITIONALLY, SIX STERILE, UNUSED STARCLOSE SE DEVICES FROM THE SAME LOT WERE RETURNED FOR EVALUATION. INVESTIGATION OF THESE DEVICES IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE COMPLAINT DEVICE WAS NOT RETURNED, THE CUSTOMER RETURNED SIX UNUSED SAMPLE DEVICES FROM THE SAME LOT NUMBER FOR EVALUATION. ALL SIX DEVICES WERE FUNCTIONALLY TESTED RESULTING IN SUCCESSFUL DEPLOYMENT; CLOSURE WAS ACHIEVED ON THE TISSUE MODEL, AND ACCESS PORTS WERE SUCCESSFULLY UTILIZED TO UNLOCK AND RETRACT THE THUMB ADVANCER. BASED ON THE EVALUATION FINDINGS, THE DEVICES PERFORMED ACCORDING TO SPECIFICATIONS. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED.

    Description of Event or Problem · 1

    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 UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED. IT WAS NOT SPECIFIED HOW HEMOSTASIS WAS ACHIEVED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, 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 910246H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention