BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE¿

    MDR report key: 23394808 · Received October 27, 2025

    Report

    Report Number
    2024168-2025-11233
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648079474
    PMA / PMN Number
    P050007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY SPLITTING THE SHEATH WAS CONFIRMED BASED ON THE RETURNED DEVICE CONDITION. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE OBSERVED EVIDENCE OF DAMAGE TO THE SHEATH INDICATES THERE WAS DEVICE ANGLE CHANGED DURING THUMB ADVANCER/SLIDER STROKE SUCH THAT GARAGE LEAVES INTERACTED WITH SHEATH AND CONTRIBUTED TO THE REPORTED DIFFICULTY SPLITTING THE SHEATH (FAILURE TO SPLIT THE SHEATH) AND NOTED DAMAGES. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4: CORRECTED MODEL # FROM UNK STARCLOSE SE TO 14679-02. D4: CORRECTED CATALOG # FROM UNK STARCLOSE SE TO 14679-02. D4: CORRECTED LOT # FROM UNKNOWN TO 5070841. D4: CORRECTED PRIMARY UDI NUMBER FROM UNKNOWN TO (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF A STARCLOSE DEVICE, THE SHEATH FAILED TO SPLIT. THE DEVICE FAILED TO ACHIEVE HEMOSTASIS WHICH RESULTED IN THE USE OF AN UNKNOWN METHOD. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342221 STARCLOSE SE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 14679-02 5070841 08717648079474

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown