BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21657515 · Received March 20, 2025

    Report

    Report Number
    2024168-2025-02928
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 14, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS NOT CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. BASED ON THE REPORTED INFORMATION AND OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IT IS LIKELY THAT AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. 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: LOT # CORRECTION FROM 4101241 TO 5011641. D4: EXPIRATION DATE CORRECTION FROM 9/30/2026 TO 12/31/2026. D4: PRIMARY UDI NUMBER CORRECTION FROM (B)(4). H4: CORRECTION DEVICE MFG DATE FROM 10/12/2024 TO 1/16/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING A PROSTYLE AFTER A FEMORAL ABLATION USING AN 8F SHEATH. REPORTEDLY, WHEN THE PLUNGER WAS REMOVED, THERE WAS NO SUTURE ATTACHED. AN ADDITIONAL PROSTYLE DEVICE 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
    453959 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 5011641

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention