BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2000828 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01120
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT APPROXIMATELY 1 INCH OF MONOFILAMENT WAS EXPOSED AT THE GUIDE WITH THE POSTERIOR CUFF AND NEEDLE TIP STILL ATTACHED TO THE RAIL END. THE ANTERIOR CUFF AND LINK WERE ENGAGED TO THE ANTERIOR NEEDLE TIP. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS BROKEN FROM THE POSTERIOR CUFF. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE; IF THE LINK BROKE FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING PLUNGER WITHDRAWAL. THE LINK BREAK IS LIKELY THE RESULT OF RESISTANCE OR DRAG ENCOUNTERED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONDITION THAT MAY HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE; THEREFORE, THE CAUSE FOR THE LINK BREAK FROM THE CUFF IS UNDETERMINED. THE REPORTED EVENT OF HOW THE KNOT COULD NOT BE DELIVERED PROPERLY COULD NOT BE DETERMINED BASED ON THE RESULTS OF THE INVESTIGATION. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE UNUSED STERILE PROGLIDE DEVICE WITH THE SAME LOT NUMBER, 930196H, AS THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE COMPLAINT DEVICE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE (REPORTED AS APPROXIMATELY 2 WEEKS AGO). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE PERCLOSE PROGLIDE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE KNOT COULD NOT BE DELIVERED PROPERLY. ANOTHER PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    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-TEMECULA-CT 930196H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention