BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 19014796 · Received April 1, 2024

    Report

    Report Number
    2024168-2024-03997
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    March 12, 2024
    Report Date
    June 12, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648113154
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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.

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 - LOT # UPDATED FROM 3072041 TO 3041941 VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. LOT HISTORY RECORD (LHR) 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 THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 18F SHEATH HOLE PRIOR TO AN INTERVENTIONAL AORTOILIAC ENDOPROSTHESIS PROCEDURE. REPORTEDLY, WHEN REMOVING THE PLUNGER, NO SUTURE WAS PRESENT. THE SUTURES OF TWO NEW UNSPECIFIED DEVICES WERE SUCCESSFULLY PRE-PLACED. THE PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED DEVICE SUTURES. THERE WAS NO REPORTED 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
    1589503 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3041941 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention