BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2001592 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01193
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. USED IN A CALCIFIED VESSEL. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE THREE PROGLIDES, ARE BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE DEVICE ATTEMPTED PRE-CLOSURE PLACEMENT OF THE PERCLOSE PROGLIDE DEVICE SUTURES IN A HEAVILY CALCIFIED COMMON FEMORAL ARTERY PRIOR TO AN AAA INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER PLACING THE INITIAL PROGLIDE SUTURE, AN ATTEMPT WAS MADE TO PLACE A SECOND AND THIRD PROGLIDE DEVICE SUTURE, BUT WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS PRESENT ON THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND DURING AN ATTEMPT TO PLACE THE SUTURE FROM A FOURTH PROGLIDE DEVICE, AS THE KNOT WAS BEING ADVANCED TO THE ARTERIAL SURFACE, THE KNOT LOCKED AND COULD NOT BE ADVANCED FURTHER. A CUTDOWN WAS PERFORMED REVEALING A TEAR IN THE ARTERY, WHICH WAS SURGICALLY SUTURED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention