BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1994129 · Received February 16, 2011

    Report

    Report Number
    2024168-2011-00933
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 24, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. THE SECOND PROGLIDE IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT BOTH CUFFS CAPTURED THE NEEDLES AND THE RAIL SUTURE END WAS CUT. THIS IS INDICATIVE OF SUCCESSFUL NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL. HOWEVER, BECAUSE THE SUTURE WAS NOT RETURNED WITH THE DEVICE, IT COULD NOT BE DETERMINED IF THE SUTURE KNOT WAS ADVANCED TO THE PUNCTURE SITE OR THE SUTURE MIGHT HAVE BEEN BROKEN DURING THE KNOT ADVANCEMENT. NO MANUFACTURING OR QUALITY ISSUES WERE 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 USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURES BROKE WHILE DEPLOYING THE DEVICE. THE SAME EXPERIENCE OCCURRED WITH THE SECOND PROGLIDE DEVICE. HEMOSTASIS WAS ACHIEVED USING A THIRD PROGLIDE DEVICE. THERE WAS NO REPORTED 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 940406H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention