BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904484 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02932
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 29, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY:EVALUATION OF THE RETURNED DEVICE FOUND A NEEDLE STRIKE MARK AT THE POSTERIOR FOOT AND THE POSTERIOR NEEDLE WAS BENT AT THE PROXIMAL END. THIS IS CONSISTENT WITH THE POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR POCKET DURING NEEDLE DEPLOYMENT. THE POSTERIOR NEEDLE WOULD NOT ENGAGE WITH THE POSTERIOR CUFF RESULTING IN THE CUFF NOT EJECTING FROM THE FOOT POCKET. WHEN THE PLUNGER WAS RETRACTED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE LINK PULLING FROM THE POSTERIOR CUFF. DURING LAB TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF, RESULTING IN THE POSTERIOR CUFF MISS AND SUBSEQUENT LINK DETACHMENT FROM THE ANTERIOR CUFF, IS NEEDLE DEFLECTION 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. A 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 A FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. THE DEVICE WAS REMOVED UNEVENTFULLY AND THE METHOD THAT HEMOSTASIS WAS ACHIEVED WAS NOT REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT REVISION SURGERY HAS BEEN PERFORMED.

    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 910406H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention