BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904801 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02892
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 27, 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: EVALUATION OF THE RETURNED DEVICE FOUND THE DEVICE WAS PARTIALLY DEPLOYED. THE PLUNGER WITH THE ANTERIOR NEEDLE TIP WAS NOT RETURNED. THE SHEATH, GUIDE, FOOT AND LEVER WERE FOUND TO BE NORMAL AND UNDAMAGED. THE ANTERIOR CUFF WAS STILL IN THE FOOT POCKET WITH ITS TABS INTACT. THE POSTERIOR CUFF HAD BEEN CAPTURED AND WAS ATTACHED TO THE NEEDLE TIP. THE POSTERIOR AND ANTERIOR FOOT WAS EXAMINED FOR NEEDLE STRIKE MARKS AND NONE WERE DETECTED INDICATING THE NEEDLE WAS DEFLECTED OUTSIDE OF THE FOOT POCKET. BASED ON THE INVESTIGATION FINDINGS, AN ANTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE ANTERIOR CUFF REMAINING THE FOOT POCKET AND THE POSTERIOR BEING CAPTURED. 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. THE POSTERIOR PORTION OF THE FOOT WAS FOUND TO BE BROKEN OFF AND NOT RETURNED. DUE TO THE BROKEN POSTERIOR FOOT THE NEEDLE TRAJECTORY TEST COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR FOOT BREAK IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. PATIENT ANATOMICAL CONDITIONS SUCH AS OBESITY AND CALCIFICATION CAN INTERFERE WITH NEEDLE DEPLOYMENT, CAUSING THE NEEDLE TO DEFLECT AND STRIKE THE FOOT, BREAKING IT. CALCIFICATION OR OTHER BODY MATERIAL TRAPPED UNDER THE FOOT DURING DEPLOYMENT CAN INTERFERE AND MAY BREAK THE FOOT. ALSO, THE FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING DEPLOYMENT CAN PUT PRESSURE ON THE FOOT CAUSING IT TO BREAK. NO MANUFACTURING OR QUALITY INSPECTION ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE EVALUATION SUMMARY PROVIDED IN MEDWATCH FOLLOW UP#1. THE PARAGRAPH THAT READS: THE POSTERIOR AND ANTERIOR FOOT WAS EXAMINED FOR NEEDLE STRIKE MARKS AND NONE WERE DETECTED INDICATING THE NEEDLE WAS DEFLECTED OUTSIDE OF THE FOOT POCKET WAS INCORRECT. IT SHOULD HAVE BEEN: THE ANTERIOR FOOT WAS EXAMINED FOR NEEDLE STRIKE MARKS AND NONE WERE DETECTED INDICATING THE NEEDLE WAS DEFLECTED OUTSIDE OF THE FOOT POCKET. (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT IMPLANT DISLODGED WHILE PASSING THROUGH A CALCIFIED LESION. THE STENT WAS REMOVED FROM THE ANATOMY ON THE STENT DELIVERY SYSTEM (SDS). NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTED LITTLE BENEFIT AND FACIAL NERVE STIMULATION WHEN USING THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. THE PATIENT HAS DISCONTINUED USE OF THE DEVICE.

    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 920416H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention