BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4862097 · Received June 23, 2015

    Report

    Report Number
    2024168-2015-03503
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 23, 2015
    Report Date
    June 9, 2015
    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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A CONCLUSIVE CAUSE FOR THE REPORTED EXPERIENCE AND PATIENT EFFECTS COULD NOT BE DETERMINED. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH (B)(4) WAS RECEIVED CONTAINING THE FOLLOWING INFORMATION. EVENT DESC: PATIENT HAD ANGIO WITH RIGHT GROIN ACCESS. PERCLOSE DEPLOYED AND FAILED; UNABLE TO FEEL PULSE TO RIGHT FOOT. X-RAY SHOWS POSSIBLE OBSTRUCTION TO PARTICLE IN RLE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? DEVICE SHOULD HAVE CLOSED THE ARTERY WITHOUT OCCLUDING ARTERY. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407103 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention