BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 25305146 · Received May 27, 2026

    Report

    Report Number
    2024168-2026-02152
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE 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 INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED SUTURE SEPARATION DURING KNOT ADVANCEMENT COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO SUTURE DETACHMENT DURING KNOT ADVANCEMENT MAY INCLUDE, BUT ARE NOT LIMITED TO, TENSIONING ANGLE NOT COAXIAL, PUSHING MORE THAN TENSIONING THE RAIL LIMB, USE OF FORCEPS. IN THIS CASE, IT IS POSSIBLE THAT THE TENSIONING OF THE SUTURE WAS NOT COAXIAL DURING KNOT ADVANCEMENT AND CONTRIBUTED TO THE REPORTED SUTURE SEPARATION. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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. ATTACHMENT: MEDWATCH REPORT.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "PERCLOSE PROSTYLE SUTURE MEDIATED CLOSURE AND REPAIR SYSTEM, (B)(4), LOT: 5120543, REF: (B)(4). PROVIDER STATES THAT SUTURES TORE WHEN THEY WERE CLOSING IT". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629268 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 5120543 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1