BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 6213771 · Received December 29, 2016

    Report

    Report Number
    2024168-2016-09347
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 29, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OTHER PERCLOSE PROGLIDE DEVICE IS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBER. EVALUATION SUMMARY: VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE UNKNOWN DEVICE FAILURE WAS UNABLE TO BE CONFIRMED AS ALL THE DEVICE COMPONENTS WERE NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING TWO PROGLIDE DEVICES VIA A 6FR SHEATH AFTER A CORONARY INTERVENTION. REPORTEDLY, BOTH PROGLIDE DEVICES FAILED. THE SITE REPORTER COULD NOT RECALL THE SPECIFIC FAILURE. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864582 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 6092642

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SHEATH: 6FRHEPARIN