BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22328727 · Received June 25, 2025

    Report

    Report Number
    2024168-2025-06440
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    May 8, 2025
    Report Date
    September 2, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE DETACHMENT COULD NOT BE TESTED SOME COMPONENTS WERE NOT RETURNED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE 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 ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO SUTURE SEPARATION DURING KNOT ADVANCEMENT INCLUDE, BUT ARE NOT LIMITED TO, USER ERROR (PUSHING MORE THAN TENSIONING THE RAIL LIMB, LEVER DEPLOYED EARLY OR EXCESSIVE SUTURE TENSION) OR SUTURE/ NICK DAMAGE. THE TREATMENT APPEARS TO BE RELATED 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 NUMBER UPDATED FROM 4061841 TO 4022741 D4: EXPIRATION DATE CORRECTED FROM 5/31/2026 TO 1/31/2026 D4: PRIMARY UDI NUMBER CORRECTED FROM (B)(4). H4: DEVICE MFG DATE CORRECTED FROM 6/18/2024 TO 2/27/2024

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AT THE MOMENT OF CLOSING THE ACCESS, THE SUTURE THREAD DETACHED INSIDE THE VESSEL, CAUSING HEAVY BLEEDING. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WAS 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
    1130056 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4022741 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention