BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20728421 · Received November 19, 2024

    Report

    Report Number
    2024168-2024-13706
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 29, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. EIGHT STERILE/UNUSED DEVICES WITH LOT # 4090241 WERE RETURNED AND WERE SUCCESSFULLY TESTED WITH NO ANOMALIES NOTED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED PLUNGER RETRACTION PROBLEM AND IRREGULAR APPEARANCE COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO PLUNGER RETRACTION PROBLEM INCLUDE, BUT ARE NOT LIMITED TO, USER CLOSES FOOT BEFORE SUTURE DEPLOYMENT (I.E., BEFORE PLUNGER FULLY RETRACTED PROXIMALLY) OR SUTURE SNAG. THE REPORTED SUTURE WAS TOO SHORT WAS LIKELY DUE TO SUTURE GETTING SNAGGED/CAUGHT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3: DATE OF EVENT ESTIMATED AS (B)(6) 2024 .

    Description of Event or Problem · 0

    IT WAS REPORTED AS A GENERAL COMMENT STATING, "THE PROSTYLE DEVICE HAS FAILED TO DEPLOY PROPERLY IN THE PAST COUPLE OF DAYS." THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. 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
    1996326 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4090241 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention