BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2000697 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01148
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 31, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE POSTERIOR NEEDLE TIP WAS BROKEN OFF AT THE CRIMP TAB AREA AND THE POSTERIOR PORTION OF THE FOOT WAS BROKEN OFF. THE BROKEN PARTS WERE NOT RETURNED. THE PLUNGER, CUFFS AND LINK WERE ALSO NOT RETURNED WITH THE DEVICE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR FOOT BREAK IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. PATIENTS ANATOMICAL CONDITIONS SUCH AS OBESITY AND CALCIFICATION CAN INTERFERE WITH NEEDLE DEPLOYMENT, CAUSING THE NEEDLE TO DEFLECT AND STRIKE THE FOOT, BREAKING THE NEEDLE TIP AND THE FOOT. CALCIFICATION OR OTHER BODY MATERIAL TRAPPED UNDER THE FOOT DURING DEPLOYMENT CAN INTERFERE AND MAY BREAK THE FOOT AND A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING DEPLOYMENT CAN PUT PRESSURE ON THE FOOT CAUSING IT TO BREAK. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 940346H

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention