BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1934925 · Received December 21, 2010

    Report

    Report Number
    2953144-2010-03319
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PLUNGER, LINK, ANTERIOR NEEDLE, AND BOTH CUFFS WERE NOT RETURNED WITH THE DEVICE, THE SCOPE OF THIS INVESTIGATION WAS LIMITED. INSPECTION OF THE RETURNED DEVICE REVEALED AN UNDISTURBED POSTERIOR NEEDLE, INDICATING THAT IT WAS DEFLECTED AWAY FROM THE POSTERIOR FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT AS DESIGNED. BECAUSE THE CUFF DID NOT CAPTURE THE NEEDLE TIP DURING THE NEEDLE DEPLOYMENT, THE PRE-TIED SUTURE KNOT WAS UNRAVELED AND THE SUTURE COULD NOT BE RETRIEVED WHEN RETRACTING THE NEEDLE PLUNGER AS OBSERVED. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL; THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT FAILURE TO RETRIEVE THE SUTURE 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. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. NO MANUFACTURING OR QUALITY ISSUES WERE 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 PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A POSTERIOR CUFF MISS OCCURRED. HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 940286H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention