BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 23514438 · Received November 10, 2025

    Report

    Report Number
    2024168-2025-11455
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 21, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 AS THE SUTURE WAS 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. CORRECTIONS: D4 - LOT #: UPDATED FROM 4091041 TO 5051041. D4 - EXPIRATION DATE: UPDATED FROM 8/31/2026 TO 4/30/2027. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4). H4 - DEVICE MFR DATE: UPDATED FROM 9/10/2024 TO 5/10/2025.

    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 A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE USING A 6F SHEATH. REPORTEDLY, A SUTURE BREAK OCCURRED WHEN PULLING THE BLUE RAIL SUTURE AND USING THE SUTURE TRIMMER TO ADVANCE THE KNOT . MANUAL ARTERIAL COMPRESSION WAS APPLIED 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
    2615404 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 5051041 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown