BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 4260130 · Received November 18, 2014

    Report

    Report Number
    2024168-2014-07533
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT AN IPSILATERAL FEMORAL VENOUS SHEATH WAS USE WITH THE STARCLOSE SE DEVICE. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE SE VASCULAR CLOSURE SYSTEM DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING SPECIAL PATIENT POPULATIONS: PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE PERCLOSE PROGLIDE DEVICE, REFERENCED WAS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A STARCLOSE SE DEVICE WAS USED; HOWEVER, PULLED OUT OF THE ARTERY BEFORE CLIP DEPLOYMENT. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE AND STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745969 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FR