BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904795 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02885
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    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: EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER/NEEDLE ASSEMBLY, ANTERIOR AND POSTERIOR CUFFS AND LINK MATERIAL WERE NOT RETURNED, WHICH LIMITED THE SCOPE OF THIS INVESTIGATION. THE POSTERIOR NEEDLE HAD BEEN EJECTED FROM THE POSTERIOR NEEDLE SHAFT AND WAS ATTACHED TO APPROXIMATELY 1 INCH OF SUTURE. THE SUTURE PRE-FORMED KNOT WAS STILL INTACT WITHIN THE DEVICE AND BLOW THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT INDICATING THE POSTERIOR CUFF HAD BEEN EJECTED FROM THE POSTERIOR FOOT. THE POSTERIOR NEEDLE TIP WAS EXAMINED AND DAMAGE TO THE NEEDLE TIP AND BARB WAS DETECTED. THE DAMAGE WAS CONSISTENT WITH THE NEEDLE STRIKING THE POSTERIOR CUFF AND EJECTING THE CUFF FROM THE POSTERIOR FOOT LEAVING THE BLOW THROUGH MARKS ON THE POSTERIOR FOOT. THERE WAS NO OTHER DETECTED DAMAGE OR ANOMALY TO THE DEVICE. A POSSIBLE CAUSE FOR THE NEEDLE TO CUFF MISS IS 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. HOWEVER, NONE OF THESE POSSIBLE CAUSES COULD BE CONFIRMED AS NO ANATOMICAL INFORMATION WAS SUPPLIED. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST NEEDLE TRAJECTORY AND THE RESULTS WERE SUCCESSFUL. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT AND DETECTED FAILURE MODE IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY INFORMATION RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER WAS NOT HOLDING POSITION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE 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 920326H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention