BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22561288 · Received July 21, 2025

    Report

    Report Number
    2024168-2025-07513
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. THE ADDITIONAL DEVICE REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO 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: CORRECTED LOT NUMBER FROM 4012341 TO 4020741. D4: CORRECTED EXPIRATION DATE FROM 12/31/2025 TO 1/31/2026. D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4). H4: CORRECTED DEVICE MFG DATE FROM 1/23/2024 TO 2/7/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CLOSURE OF AN UNSPECIFIED ACCESS SITE USING A PROSTYLE DEVICE AFTER AN UNKNOWN PROCEDURE. REPORTEDLY, TWO PROSTYLE UNITS DID NOT COME WITH SUTURES DURING THE STEP-BY-STEP USAGE PROCESS. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. 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
    944312 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4020741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention