BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 21242760 · Received January 27, 2025

    Report

    Report Number
    2024168-2025-00879
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    December 6, 2024
    Report Date
    February 17, 2025
    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
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. 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 MANUFACTURE, DESIGN OR LABELING. D4: LOT # UPDATED FROM 4050141 TO 4041741.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH 2 PROGLIDE DEVICES USING A SMALL-BORE SHEATH AFTER AN INTERVENTIONAL BIOPSY PROCEDURE. REPORTEDLY, WITH THE FIRST DEVICE, THE DOCTOR FELT AN ABNORMAL ¿GIVE¿ AFTER DEPRESSING THE PLUNGER. PRIOR TO REMOVING THE PLUNGER OR CLOSING THE LEVER/FOOT, THE ENTIRE DEVICE, INCLUDING THE KNOT IN THE PRE-DEPLOYED POSITION, CAME OUT OF THE PATIENT ANATOMY AS BACKWARD TENSION WAS BEING APPLIED TO THE PROGLIDE. A SECOND DEVICE WAS ATTEMPTED, HOWEVER, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTED AFTER THE PLUNGER WAS REMOVED. A NON-ABBOTT DEVICE WAS PLACED BUT ALSO FAILED TO ACHIEVE HEMOSTASIS. IT IS BELIEVED THAT THE EXPOSED NEEDLES CAUSED A LACERATION OF THE ARTERY, CREATING A LARGER HOLE; THEREFORE, A RETROGRADE FEMORAL PUNCTURE WAS PERFORMED ON THE LEFT LEG TO CONDUCT AN ANGIOGRAM OF THE RIGHT LEG. IT WAS FOUND THAT THE SFA TO DISTAL POPLITEAL WAS THROMBOSED. A SURGICAL CUTDOWN WAS PERFORMED ON THE RIGHT SIDE AT THE FEMORAL ARTERY TO PERFORM AN EMBOLECTOMY. TWO SEPARATED FOOTPLATES FROM THE FIRST PROGLIDE DEVICE WERE FOUND OUTSIDE AND NEAR THE ARTERY, AS WELL AS IN THE CLOT RETRIEVED FROM THE EMBOLECTOMY. ALL DEVICE COMPONENTS ARE BELIEVED TO HAVE BEEN REMOVED FROM THE PATIENT ANATOMY. DURING THE SURGERY, A SURGICAL PATCH WAS USED TO REPAIR THE ARTERY, AND HEMOSTASIS WAS ACHIEVED. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780753 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-05 4041741 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention