BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1946357 · Received January 4, 2011

    Report

    Report Number
    2024168-2011-00011
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY CLIP-DEPLOYED WITH ALL COMPONENTS IN APPROPRIATE POST CLIP-DEPLOYMENT POSITION. THE RETURNED DEVICE WAS FULLY INSPECTED AND NO ABNORMAL OBSERVATIONS WERE DETECTED THAT COULD CONTRIBUTE TO THE REPORTED PRODUCT EXPERIENCE. THE LOCATOR WINGS WERE FULLY COLLAPSED, THE SHEATH WAS NORMALLY SLIT, AND THE DELIVERY TUBESET WAS NORMAL FOR A FULLY CLIP-DEPLOYED DEVICE. BASED ON THE INVESTIGATION, THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS AND A CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. 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 IN TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT AND REMOVAL OF THE DEVICE FROM THE ANATOMY, HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. AFTER THE PROCEDURE, THE DEVICE WAS INSPECTED AND IT WAS OBSERVED THAT THE CLIP WAS ON THE DISTAL END OF THE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 830416H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention