BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20784423 · Received November 26, 2024

    Report

    Report Number
    2024168-2024-13966
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    October 30, 2024
    Report Date
    March 7, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    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 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    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. 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. CORRECTIONS: D4 - LOT #: UPDATED FROM 3071141 TO 3042541. D4 - EXPIRATION DATE: UPDATED FROM 6/30/2025 TO 3/31/2025. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 7/11/2023 TO 4/25/2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE OF A RIGHT FEMORAL ARTERY USING TWO PROSTYLE DEVICES RELATED TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER REMOVING THE PLUNGER THE SUTURE DID NOT APPEAR FOR BOTH DEVICES. A NEW 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
    2574115 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 3042541 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention