BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3900005 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04163
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED AGE-REPORTED AS BORN IN 1946. THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    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. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A LEFT FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH AN 8F SHEATH AFTER A STAGED PERCUTANEOUS CORONARY INTERVENTION PROCEDURE ON (B)(6) 2014. REPORTEDLY, AFTER HEMOSTASIS WAS ACHIEVED A HEMATOMA WAS DISCOVERED. THE HEMATOMA WAS CAUSED BY THE USE OF THE CLOSURE DEVICE. MANUAL COMPRESSION WAS APPLIED AND EPINEPHRINE AND LIDOCAINE WERE INJECTED TO TREAT THE HEMATOMA. THE HEMATOMA WAS CONSIDERED RESOLVED WITHOUT SEQUELAE THE SAME DAY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. ANOTHER STAGED PROCEDURE WAS PERFORMED ON (B)(6) 2014: IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A SUBSEQUENT PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, A HEMATOMA OCCURRED AT THE RIGHT FEMORAL AREA. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO TREAT THE HEMATOMA. THE HEMATOMA RESOLVED THE NEXT DAY. THE PATIENT WAS HOSPITALIZED ONE DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378142 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R