BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904635 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02866
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 18, 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). 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

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND A PARTIALLY DEPLOYED DEVICE. THE POSTERIOR CUFF WAS CAPTURED AND ATTACHED TO THE NEEDLE TIP. THE COMPLETE SUTURE HAD BEEN PULLED DISTALLY OUT OF THE DEVICE BUT WAS STILL ATTACHED TO THE DEVICE BY THE ANTERIOR CUFF. THE ANTERIOR CUFF REMAINED IN THE FOOT POCKET WITH IT IS TABS INTACT. DURING TESTING A PROXY PLUNGER WAS INSERTED AND THE NEEDLE TRAJECTORY WAS FOUND TO BE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, AN ANTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE ANTERIOR CUFF REMAINING IN THE FOOT POCKET. NO NEEDLE STRIKE MARKS WERE DETECTED AT THE ANTERIOR FOOT POCKET. THIS INDICATES THE NEEDLE WAS DEFLECTED AWAY FROM THE POCKET DURING DEPLOYMENT. BECAUSE THE NEEDLE DID NOT ENGAGE THE ANTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE SUTURE WOULD NOT BE PRESENT. THE MOST PROBABLE ROOT CAUSE FOR THE ANTERIOR CUFF MISS AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS IS DUE TO NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT POSSIBLY CAUSED BY INTERACTION WITH ANATOMY OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. 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 BY SVC REPORT THAT THE BED WAS NOT COMMUNICATING. 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 930226H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention