BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 19943519 · Received August 8, 2024

    Report

    Report Number
    2024168-2024-09400
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 15, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PERCLOSE PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    E4 - INITIAL REPORT SENT TO FDA UPDATED FROM NO TO YES. G2 - REPORT SOURCE UPDATED FROM HEALTH PROFESSIONAL; COMPANY REPRESENTATIVE TO FACILITY. H10 - RELATED REPORT NUMBERS ADDED. ATTACHMENT: MEDSUN REPORT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED CUFF MISS COULD NOT BE TESTED DUE TO SOME DEVICE COMPONENTS NOT BEING RETURNED. 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 AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION AND 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A CARDIAC ABLATION INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED FOR FIVE PROGLIDE DEVICES. THE SHEATH WAS UPSIZED TO A LARGE BORE SHEATH AND THE CARDIAC ABLATION PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH A FIGURE OF EIGHT STITCH. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, A MEDSUN REPORT WAS RECEIVED STATING: DESCRIBE THE EVENT OR PROBLEM: FIVE SEPERATA PERCLOSE DEVICE SUTURE FAILURES. FAILED PERCLOSES REMOVED FROM PATIENT AND NEW PERCLOSE DEVICES INSERTED AND DEPLOYED. FOUR FAILED FROM LOT NUMBER 4052341 AND ONE FAILED FROM LOT NUMBER 4040442.] NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397151 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 4040442 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Required Intervention