BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2040224 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02378
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 7, 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
    TX, 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. ESTIMATED AGE OF THE PATIENT WHO WAS REPORTED TO BE (B)(6). ESTIMATED WEIGHT OF THE PATIENT WHO WAS REPORTED TO BE APPROXIMATELY (B)(6). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER, CUFFS, LINK, NEEDLE TIP AND MONOFILAMENT WERE NOT RETURNED. BASED ON THE CONDITION OF THE RETURNED DEVICE, DUE TO THE MISSING PARTS, THE CAUSE OR CONFIRMATION OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE PROBABLE CAUSES FOR THE SUTURE TO PULL OUT FROM THE ARTERY IS TOO MUCH TENSION APPLIED DURING KNOT ADVANCEMENT, INSUFFICIENT TISSUE CAPTURE OR THE DEVICE WAS DEPLOYED OUTSIDE THE ARTERY. HOWEVER, THE MONOFILAMENT WAS NOT RETURNED WHICH IS AN INTEGRAL PART OF THIS INVESTIGATION; THEREFORE, THE ROOT CAUSE WAS UNDETERMINED FOR THIS INCIDENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN AN ATTEMPT WAS MADE TO HARVEST THE SUTURES THEY CAME OUT OF THE PATIENT ANATOMY. A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 950386H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ANGIOMAX