BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 19905802 · Received August 5, 2024

    Report

    Report Number
    2024168-2024-09184
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 18, 2024
    Report Date
    September 16, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. FACTORS THAT MAY CONTRIBUTE TO THE POSITIONING PROBLEM AND LOSS OF VESSEL ACCESS INCLUDE, BUT ARE NOT LIMITED TO, USER TECHNIQUE, DEVICE WAS NOT GENTLY PULLED UP TO THE ANTERIOR WALL AND WAS INADVERTENTLY PULLED OUT OF THE ACCESS SITE OR PATIENT ANATOMICAL CONDITIONS (CALCIFICATION). THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. ADDITIONAL INFORMATION: D4 - LOT NUMBER UPDATED FROM UNKNOWN TO 4051342. D4 - UDI NUMBER UPDATED FROM (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. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE AFTER A TWO-HOUR ORBITAL ATHERECTOMY AND PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. A 6F SHORT SHEATH WAS INSERTED PRIOR TO THE PROCEDURE AND UPSIZED TO A 7F LONG SHEATH. DURING THE PROCEDURE A HEMATOMA WAS NOTED AROUND THE SHEATH AT PUNCTURE SITE. REPORTEDLY, AFTER THE PROCEDURE, A LARGE AMOUNT OF BLEEDING WAS NOTED AT THE FEMORAL PUNCTURE SITE WHEN EXCHANGING THE LONG SHEATH VIA A LONG 0.35" GUIDE WIRE FOR THE PROSTYLE DEVICE. FIRM PRESSURE WAS USED TO MINIMIZE BLEEDING. CORRECT PLACEMENT OF THE PROSTYLE IN THE HIGH BODY MASS INDEX PATIENT WAS DIFFICULT. ALTHOUGH THERE WAS PULSATILE FLOW THROUGH THE MARKER LUMEN UPON SHALLOW INSERTION, MARKING STOPPED WHEN ADVANCING INTO ARTERY; THEN PULSATILE FLOW THROUGH THE MARKER LUMEN RESUMED AGAIN ONCE DEEPER IN PUNCTURE SITE. THE LOCATION OF THE PROSTYLE WAS UNCERTAIN DUE TO THE PATIENT'S SIZE AND BLEEDING FROM THE SITE. THE PHYSICIAN ELECTED TO REMOVE THE PROSTYLE WITHOUT DEPLOYING. THE PHYSICIAN THEN REINSERTED A SHORTER 8F FEMORAL SHEATH TO MINIMIZE BLEEDING WHILE DECIDING NEXT STEPS. AFTER REASSESSING, THE PHYSICIAN INTENDED TO ATTEMPT A TWO-PROSTYLE DEPLOYMENT STRATEGY. A SECOND PROSTYLE DEVICE WAS OPENED. THE 8F SHORT SHEATH WAS EXCHANGED FOR THE SECOND PROSTYLE DEVICE. THE PHYSICIAN ATTEMPTED TO CONFIRM POSITION OF THE PROSTYLE DEVICE USING ULTRASOUND GUIDANCE AND MONITORING BLOOD FLOW VIA THE MARKER LUMEN. HOWEVER, AFTER INSERTING THE SECOND PROSTYLE DEVICE, THE PHYSICIAN AGAIN EXPERIENCED DIFFICULTY CONFIRMING THE LOCATION OF THE PROSTYLE DEVICE DUE TO BLEEDING AROUND THE SITE. THE PHYSICIAN ELECTED TO EXCHANGE THE PROSTYLE AGAIN FOR THE 8F SHEATH. HOWEVER, DURING THIS STEP, WIRE ACCESS WAS LOST RESULTING IN BAILING OUT OF THE CLOSURE ATTEMPT WITHOUT DEPLOYING THE SECOND PROSTYLE DEVICE. THIRTY MINUTES OF HIGH-PRESSURE MANUAL COMPRESSION AND A FEMOSTOP ACHIEVED 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
    2274730 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4051342 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention