BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 20147826 · Received September 5, 2024

    Report

    Report Number
    2024168-2024-10450
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    August 20, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648113154
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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

    A VISUAL INSPECTION ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MALPOSITION OF THE SUTURE COULD NOT BE TESTED DUE TO MISSING COMPONENTS. 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED DEVICE ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO MALPOSITION OF DEVICE (FAILURE TO DEPLOY) THE SUTURE INCLUDE, BUT ARE NOT LIMITED TO, AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY (MISPLACEMENT/SHALLOW), FRIABLE VESSEL, OR PARTIAL CAPTURE OF VESSEL 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. D4 CORRECTION: LOT NUMBER UPDATED FROM 3100741 TO 3071842.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROGLIDE AFTER A DIAGNOSTIC PROCEDURE USING A 6F SHEATH. REPORTEDLY, AFTER PERFORMING STEPS 1-4 WITHOUT ISSUE, WHEN PULLING THE DEVICE OUT OF THE ANATOMY, THE THREAD CAME OUT IN A KNOTTED CONDITION. ANOTHER DEVICE WAS USED 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
    2287252 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 3071842 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention