BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1953060 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00101
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 29, 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
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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 ABOUT 2 INCHES OF MONOFILAMENT WAS EXPOSED AT THE GUIDE WITH THE POSTERIOR CUFF AND NEEDLE TIP STILL ATTACHED TO THE RAIL END. THE ANTERIOR CUFF WAS STILL LOADED ON THE FOOT AND THE LINK STILL ATTACHED TO THE CUFF. THERE WAS NO NEEDLE STRIKE MARK ON THE FOOT. BASED ON THE EVIDENCE FOUND ON THE RETURNED DEVICE, THE ANTERIOR CUFF WAS MISSED AND THIS CONFIRMED THE REPORTED EVENT. DURING THE INVESTIGATION, PLUNGER WAS INSERTED AND THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL WERE ACCEPTABLE, THE ANTERIOR CUFF WAS CAPTURED SUCCESSFULLY. BECAUSE LAB TESTING OF THE DEVICE RESULTED IN SUCCESSFUL CUFF RETRIEVAL, THE MOST PROBABLE ROOT CAUSE FOR THE ANTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE DURING NEEDLE DEPLOYMENT. THERE WERE NO MANUFACTURING OR QUALITY ISSUES DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. REVIEW OF THE DEVICE LOT 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 COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT 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 940316H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention