BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4243838 · Received November 11, 2014

    Report

    Report Number
    2024168-2014-07353
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 29, 2014
    Report Date
    November 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER PERCLOSE PROGLIDE DEVICE, REFERENCED WAS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY ANGIOGRAM, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS PRESENT. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED BUT WITH THE SAME RESULTS, NO SUTURE WAS PRESENT WHEN THE NEEDLE PLUNGER WAS REMOVED. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A THIRD PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725800 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40915K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6-FRENCH