BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1905154 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02954
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 4, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.DEVICES #1 AND #3 - PROGLIDE (PART #12673-03; LOT #930396H), ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND AN ANTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE ANTERIOR CUFF REMAINING IN THE FOOT POCKET AND THE ANTERIOR NEEDLE WAS UNDISTURBED. BECAUSE THE ANTERIOR NEEDLE DID NOT ENGAGE WITH THE CUFF, THE SUTURE COULD NOT BE RETRIEVED WHEN RETRACTING THE NEEDLE PLUNGER. BECAUSE THE LINK WAS HELD ON ONE END BY THE ANTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE REMOVAL OF THE SUTURE FROM THE DEVICE, THIS RESULTED IN THE LINK DETACHING FROM THE POSTERIOR CUFF. DURING TESTING, THE PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE ANTERIOR CUFF MISS AND SUBSEQUENT LINK DETACHMENT FROM THE POSTERIOR CUFF IS NEEDLE DEFLECTION DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. HEAVILY CALCIFIED ARTERIES COULD DEFLECT THE NEEDLES DURING DEPLOYMENT. THE INSTRUCTIONS FOR USE (IFU), UNDER SPECIAL PATIENT POPULATIONS SECTION, STATES: THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. THE PROGLIDE WAS REMOVED AND A SECOND AND THIRD PROGLIDE DEVICE WERE USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A FOURTH PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTED LITTLE BENEFIT AND FACIAL NERVE STIMULATION WHEN USING THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. THE PATIENT HAS DISCONTINUED USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 930376H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention