BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 22817314 · Received August 15, 2025

    Report

    Report Number
    2024168-2025-08542
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 19, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. H10: SECOND MEDWATCH REPORT MW5173289 ATTACHED FOR THE ADDITIONAL PROGLIDE DEVICE THAT WAS TESTED OUTSIDE THE PATIENT ANATOMY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. IT IS POSSIBLE THE GUIDE BROKE AND OR SEPARATED DURING INSERTION DUE TO TOO STEEP TRAJECTORY ANGLES IN RELATION TO THE VESSEL TRACK; HOWEVER, THIS CANNOT BE CONFIRMED. STERILE UNITS FROM THE SAME LOT WERE RETURNED AND INSPECTED WITH NO ABNORMALITIES SHOWN. BASED ON THE REPORTED INFORMATION IT IS POSSIBLE THE GUIDE BROKE AND OR SEPARATED DURING INSERTION. FACTORS THAT CONTRIBUTE TO GUIDE SEPARATION, INCLUDE, BUT ARE NO LIMITED TO, STEEP INSERTION ANGLE IN REFERENCE TO THE VESSEL TRACK, CALCIFICATION, ROTATION OF THE DEVICE WITH THE FOOT DEPLOYED AGAINST THE VESSEL WALL, EXCESSIVE FORCE. 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 TO NO.

    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 NON-ABBOTT DEVICE PROCEDURE. REPORTEDLY, THE GUIDE SEPARATED FROM THE PROGLIDE DEVICE. A SURGICAL CUTDOWN WAS PERFORMED IN AN ATTEMPT TO REMOVE THE GUIDE BUT WAS UNSUCCESSFUL. THE GUIDE WAS RETRIEVED WITH A SNARE VIA CONTRALATERAL ACCESS. HEMOSTASIS WAS ULTIMATELY ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. AN ADDITIONAL PROGLIDE DEVICE WAS TESTED OUTSIDE THE PATIENT ANATOMY AND THE USER INADVERTENTLY BROKE THE DEVICE (THE GUIDE SEPARATED) DURING HANDLING. NO ADDITIONAL INFORMATION WAS PROVIDED. 2 USER FACILITY MEDWATCH REPORTS RECEIVED THAT STATE: MW5173288: [ABBOTT PERCLOSE CLOSURE DEVICE LOT #5051741 BROKE DURING DEPLOYMENT WITH THE TIP RETAINED WITHIN THE PATIENTS' ARTERY. A SECOND ABBOTT PERCLOSE DEVICE LOT # 5051741 BROKE BUT TIP WAS NOT RETAINED. CV SURGEON CONSULTED AND RETAINED TIP REMOVED SURGICALLY. ALL ABBOTT PERCLOSE LOT #5051741 REMOVED FROM CIRCULATION AND ABBOTT NOTIFIED. REF REPORT: MW5173289.] MW5173289 [ABBOTT PERCLOSE CLOSURE DEVICE LOT #5051741 BROKE DURING DEPLOYMENT WITH THE TIP RETAINED WITHIN THE PATIENTS' ARTERY. A SECOND ABBOTT PERCLOSE DEVICE LOT # 5051741 BROKE BUT TIP WAS NOT RETAINED. CV SURGEON CONSULTED AND RETAINED TIP REMOVED SURGICALLY. ALL ABBOTT PERCLOSE LOT #5051741 REMOVED FROM CIRCULATION AND ABBOTT NOTIFIED. REF REPORT: MW5173288.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726348 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 5051741

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention