BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 22495115 · Received July 14, 2025

    Report

    Report Number
    2024168-2025-07192
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 18, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648113154
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL TESTING, DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE FAILURE TO CYCLE WAS CONFIRMED. 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 CONTRIBUTED TO DUE TO THE EVENT. THE CUFF TABS BENT INDICATE A BILATERAL CUFF MISS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTION: D9 - DEVICE AVAILABLE FOR EVALUATION: UPDATED FROM NO TO YES. H6 - COMPONENT CODE: CODE 4755 WAS REMOVED AND CODES 525, 3088 AND 562 WERE ADDED. H6 - TYPE OF INVESTIGATION: CODE 4115 WAS REMOVED AND CODE 10 WAS ADDED. H11 - ADDITIONAL MFG NARRATIVE: UPDATED, AS DEVICE WAS RETURNED.

    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. THE REPORTED DIFFICULTY 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 INFORMATION REVIEWED, 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 AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER A CARDIAC CATHETERIZATION INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED. ANOTHER PROGLIDE 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
    1677582 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 5031241 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention