BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1905013 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02913
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLUNGER, SUTURE, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED, WHICH LIMITED THE INVESTIGATION. EVALUATION OF THE RETURNED DEVICE COMPONENTS REVEALED NO ABNORMAL OBSERVATIONS THAT COULD CONTRIBUTE TO THE REPORTED NEEDLE-TO-CUFF MISS EVENT. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION AND A ROOT CAUSE FOR THE REPORTED CUFF MISS EXPERIENCE RELATED TO THE DEVICE COULD NOT BE DETERMINED. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED CUFF MISS IS POSSIBLY NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT OR THE PATIENTS ANATOMY. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING A CHECK LINES AND BAGS ALARM THAT APPEARED ON THE HOME CHOICE (HC) MACHINE DURING PRIME, THE HOME PATIENT (HP) REVEALED THAT AIR BUBBLES WERE NOTICED IN THE TUBING ON THE RED AND BLUE COLOR CLAMPS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER USING NEW SUPPLIES. DURING A FOLLOW-UP WITH THE HP, IT WAS FOUND THAT NOTHING WAS NOTICED WITH THE SUPPLIES AND USING NEW SUPPLIES RESOLVED THE ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. NO ADVERSE PATIENT EFFECT WAS REPORTED. ALTHOUGH 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 920106H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention