BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1934926 · Received December 21, 2010

    Report

    Report Number
    2953144-2010-03318
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 2, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND IT WAS DEPLOYED WITH BLOOD PRESENT IN THE DEVICE. THE CUFFS, LINK, AND SUTURE WITH THE POSTERIOR NEEDLE TIP WERE NOT RETURNED. THE PLUNGER BEING RETURNED WITHOUT THE ANTERIOR CUFF ATTACHED TO THE NEEDLE TIP INDICATES A CUFF MISS MAY HAVE OCCURRED. THE SHEATH, GUIDE, FOOT, AND LEVER WERE NORMAL AND UNDAMAGED. THE POSTERIOR AND ANTERIOR FOOT WAS EXAMINED FOR NEEDLE STRIKE MARKS AND NONE WERE DETECTED, INDICATING THE NEEDLES WERE DEFLECTED OUTSIDE OF THE FOOT POCKET. THE COMPLETE SUTURE WAS RETURNED SUTURE PULLED. THE ORIGINAL PLUNGER WAS RE-INSERTED INTO THE DEVICE TO TEST THE NEEDLE TRAJECTORY, DEPTH AND MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THESE FINDINGS ARE CONSISTENT WITH AND CONFIRM THE REPORTED NEEDLE TO CUFF MISS EVENT. BASED ON THE INVESTIGATION FINDINGS, 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 THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS RETRACTED, ONLY ONE LINK WAS RETRIEVED; A CUFF MISS OCCURRED. THE DEVICE WAS REWIRED AND ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH 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 940086H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention