BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2041953 · Received April 6, 2011

    Report

    Report Number
    2024168-2011-02406
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(6). THE DEVICE WAS NOT RETURNED AND MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. BASED ON THE INFORMATION RECEIVED WITH THE REPORTED EVENT, THERE DOES NOT APPEAR TO BE ANY INDICATION OF AN ISSUE WITH THE QUALITY OF THE PRODUCT. AS THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE LOT HISTORY RECORD COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, NO PULSATILE FLOW WAS COMING FROM THE MARKER LUMEN AS A BLOOD CLOT COULD BE SEEN IN THE LUMEN TUBE. THE DEVICE WAS REMOVED AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO FLUSH THE MARKER LUMEN AND REMOVE THE CLOT. ANOTHER PROGLIDE WAS SUCCESSFULLY USED AND ACHIEVED HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention