BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1923442 · Received December 13, 2010

    Report

    Report Number
    2953144-2010-03213
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-REDWOOD CITY
    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). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IMPROPER OR INCORRECT METHOD/INCORRECT ANATOMY (B)(4). DURING PROCESSING OF THIS COMPLAINT ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE SUPERFICIAL FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, 16 DAYS AFTER VESSEL CLOSURE THE PATIENT CAME BACK TO THE HOSPITAL WITH LEG PAIN, HYPERTENSION AND DIMINISHED PULSE. A FEMORAL ANGIOGRAM WAS PERFORMED AND IT WAS OBSERVED THAT THE PROGLIDE SUTURES HAD PINCHED THE PROFUNDA AND THE FEMORAL ARTERY WAS 80% STENOSED. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE STENOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R ANGIOMAX