BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 24378703 · Received February 18, 2026

    Report

    Report Number
    2024168-2026-00664
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 6, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE MATERIAL SEPARATION OF THE GUIDE WAS CONFIRMED. 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 ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE AND THE SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, THE GUIDE BROKE, LIKELY DURING INSERTION OR DURING MANIPULATION (POSSIBLE TORQUE) OF THE DEVICE WITH THE FOOT OPEN WHILE AGAINST THE VESSEL WALL, OR PATIENT BODY HABITUS. A BREAK IN THE GUIDE WILL DISORIENT THE FOOT TO NEEDLE ALIGNMENT AND LEAD TO A CUFF MISS WHICH IS EVIDENCED IN THE DEVICE¿S SUTURE CONDITION. FURTHER MANIPULATION OF THE DEVICE, INCLUDING CLOSING OF THE FOOT CAN CAUSE A DISLODGEMENT OF THE FOOT FROM THE GUIDE AND SEPARATION OF THE GUIDE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTIONS: D4 - LOT #: UPDATED FROM UNKNOWN TO 5112643. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) UNKNOWN TO (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF A COMMON FEMORAL VEIN USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE WITH A 5F SHEATH. REPORTEDLY, UPON REMOVAL OF THE PROGLIDE DEVICE, THE SHEATH SEPARATED INTO TWO PIECES IN THE PATIENT ANATOMY. THE DISTAL CATHETER PORTION WAS INSIDE THE PATIENT, AND THE FOOT WAS OUTSIDE THE PATIENT. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE AND NO RESISTANCE WAS NOTED. THE PHYSICIAN UTILIZED A SNARE DEVICE TO REMOVE THE BROKEN PORTION OF THE DEVICE. THE PIECE OF THE DEVICE WAS SUCCESSFULLY AND SAFELY REMOVED WITHOUT CAUSING VESSEL DAMAGE. IT WAS NOTED THAT THE DEVICE WAS STILL CONNECTED TO CONNECTING WIRES PRIOR TO REMOVAL. THE PROCEDURE WAS SUBSEQUENTLY ABANDONED, AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS 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
    449454 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 5112643 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention