BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4163481 · Received October 10, 2014

    Report

    Report Number
    2024168-2014-06582
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED AGE, REPORTED AS BORN IN 1948. IT WAS REPORTED THAT THE PROGLIDE DEVICE WAS USED IN A CALCIFIED VESSEL. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER FOUR PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO AN IMPELLA INTERVENTIONAL PROCEDURE. THE SUTURE OF THE FIRST DEVICE WAS SUCCESSFULLY PREPLACED. REPORTEDLY, A CUFF MISS OCCURRED WITH THE SECOND, THIRD AND FOURTH PROGLIDE DEVICES. THE FIFTH PROGLIDE DEVICE HAD NO KNOT PRESENT AFTER DEPLOYMENT. THE SHEATH WAS UPSIZED TO 14F AND THE IMPELLA PROCEDURE WAS COMPLETED. THE SUCCESSFULLY PRE-PLACED SUTURE OF THE FIRST PROGLIDE DEVICE WAS TIGHTENED, HEMOSTASIS WAS NOT ACHIEVED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639678 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SHEATH: 6F, 14, FIMPELLA, HEPARIN