BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3800936 · Received May 8, 2014

    Report

    Report Number
    2024168-2014-02951
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 7F SHEATH AFTER AN INTERVENTIONAL PROCEDURE FOR PERIPHERAL ARTERIAL OCCLUSIVE DISEASE. REPORTEDLY, AFTER NEEDLE DEPLOYMENT AN ANTERIOR CUFF MISS WAS FOUND. THE PROGLIDE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277938 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31019K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7F, HEPARIN