BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1951270 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00065
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. DATE OF OCCURRENCE IS AN ESTIMATED DATE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER, NEEDLES, THE COMPLETE SUTURE, POSTERIOR NEEDLE TIP, ANTERIOR AND POSTERIOR CUFFS AND LINK MATERIAL WERE NOT RETURNED. WITHOUT THE RETURN OF THESE COMPONENTS, THE SCOPE OF THIS INVESTIGATION WAS LIMITED. THERE WAS NO DETECTED DAMAGE TO THE DEVICE HANDLE, GUIDE, FOOT OR SHEATH. BLOW THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT INDICATING THE POSTERIOR CUFF HAD BEEN EJECTED FROM THE POSTERIOR FOOT. INSPECTION OF THE FOOT ASSEMBLY DID NOT DETECT ANY DAMAGE TO INDICATE A POSSIBLE CUFF MISS, NEEDLE STRIKE OR MALFUNCTION OF THE DEVICE. DURING TESTING, A PROXY PLUNGER AND NEEDLE ASSEMBLY WAS INSERTED TO TEST NEEDLE TRAJECTORY AND THE RESULTS WERE SUCCESSFUL. A POSSIBLE CAUSE FOR THE REPORTED CUFF MISS MAY HAVE BEEN 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 THE POSSIBLE CAUSES OR THE CUFF MISS COULD BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION AND THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS 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 THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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-TEMECULA-CT 940066H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention