BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 23038946 · Received September 12, 2025

    Report

    Report Number
    2024168-2025-09772
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 15, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. THE DEVICE CONDITION INDICATES THE PLUNGER MAY HAVE NOT BEEN FULLY DEPRESSED FLUSH WITH THE HANDLE SUCH THAT THE POSTERIOR NEEDLE WAS NOT BLOWN THROUGH THE POSTERIOR FOOT. 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 THE CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. D9: CORRECTED DEVICE AVAILABLE FOR EVALUATION FROM NI TO YES.

    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

    D4: CORRECTED LOT # FROM 5020241 TO 4110941. D4: CORRECTED EXPIRATION DATE FROM 1/31/2027 TO 10/31/2026. D4: CORRECTED PRIMARY UDI NUMBER UPDATED FROM (B)(4) TO (B)(4). H4: CORRECTED DEVICE MFG DATE FROM 2/2/2025 TO 11/9/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED A CUFF MISS OCCURRED. AN UNKNOWN METHOD 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
    2654775 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4110941 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention