BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE¿

    MDR report key: 21677639 · Received March 24, 2025

    Report

    Report Number
    2024168-2025-03023
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 28, 2025
    Report Date
    May 9, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648079467
    PMA / PMN Number
    P050007
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE FIRING PROBLEM COULD NOT BE CONFIRMED. THE DIFFICULT TO REMOVE IS RELATED TO THE CASE CONDITIONS AND CANNOT BE REPLICATED IN A LAB ENVIRONMENT. 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 DEVICE ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. IT IS POSSIBLE THE DEVICE POSITION CHANGED DURING DEPLOYMENT CAUSING THE CLIP TO BE CAUGHT ON THE VESSEL LOCATOR WINGS. THE CLIP ON THE VESSEL LOCATOR WINGS CONTRIBUTED TO THE DIFFICULT TO REMOVE. 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. ADDITIONAL INFORMATION: D4 - LOT # UPDATED FROM UNK TO 4073041.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY USING A STARCLOSE SE AFTER AN INTERVENTIONAL PERIPHERAL PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THERE WAS NO RESISTANCE DEPLOYING THE DEVICE. AFTER PRESSING THE #4 BUTTON, THE DEVICE WAS STUCK IN THE PATIENT. THE OPERATOR DEPLOYED THE TWO SAFETY RELEASE MECHANISMS TO RELEASE THE DEVICE. THE STARCLOSE SE WAS REMOVED WITHOUT ISSUE. THE CLIP WAS FOUND DEPLOYED ON THE END OF THE DEVICE. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA 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
    753946 STARCLOSE SE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 14679-01 4073041 08717648079467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention