BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904769 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02889
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 13, 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):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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED MISSING THE PLUNGER/NEEDLES ASSEMBLY. EVALUATION OF THE RETURNED DEVICE COMPONENTS FOUND THAT AN ANTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE ANTERIOR CUFF REMAINING IN THE FOOT POCKET WITH UNTOUCHED TABS. A NEEDLE STRIKE MARK WAS DETECTED IN THE ANTERIOR FOOT POCKET, JUST ABOVE THE ANTERIOR CUFF DAMAGING THE CUFF. BECAUSE THE ANTERIOR CUFF DID NOT ENGAGE THE ANTERIOR NEEDLE DURING NEEDLE DEPLOYMENT, THE SUTURE COULD NOT BE RETRIEVED WHEN RETRACTING THE NEEDLE PLUNGER. THE DEVICE WAS TESTED, FOR PROPER NEEDLE TRAJECTORY, BY INSERTING A PROXY PLUNGER/NEEDLE ASSEMBLY INTO THE HANDLE ASSEMBLY AND THE RESULTS WERE SUCCESSFUL WITH BOTH NEEDLES ENTERING THEIR RESPECTIVE FOOT POCKET AND THE ANTERIOR NEEDLE ENGAGING THE ANTERIOR CUFF. POSSIBLE CAUSES FOR A CUFF MISS EVENT ARE NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE PLUNGER, OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. NO ANATOMICAL INFORMATION WAS REPORTED AND THE DEPLOYMENT TECHNIQUE COULD NOT BE VERIFIED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED CUFF MISS EVENT IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE LOT HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE SIDE RAILS DO NOT CLOSE PROPERLY. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    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 A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. 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 920286H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention