BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1953238 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00147
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. AGE AT TIME OF EVENT: FACILITY REPORTER INDICATED THE PATIENT WAS IN HIS (B)(6). WEIGHT: FACILITY REPORTER INDICATED THE PATIENT ESTIMATED WEIGHT WAS (B)(6). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION OF THE RETURNED DEVICE REVEALED A POSTERIOR CUFF MISS DURING NEEDLE DEPLOYMENT AS EVIDENCED BY UNTOUCHED POSTERIOR CUFF TABS AND UNDAMAGED POSTERIOR NEEDLE, INDICATING NO ENGAGEMENT OCCURRED BETWEEN THESE 2 COMPONENTS. THE POSTERIOR CUFF MISS SUBSEQUENTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE DURING PLUNGER RETRACTION AND THIS COULD APPEAR VERY SIMILAR TO THE REPORTED SUTURE BREAK. DURING LAB TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. 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.

    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 RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PULLED OUT OF THE DEVICE BODY THE SUTURE BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT ANATOMY AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. 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 820216H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention REOPRO