BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1953169 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00120
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 2, 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 RETUNED DEVICE FOUND THE MONOFILAMENT WAS APPROXIMATELY 3/8 INCHES WERE EXPOSED AT THE GUIDE AND THE SUTURE END WAS CLEAN CUT. BOTH CUFFS WERE STILL ATTACHED TO THE LINK. THE POSTERIOR CUFF WAS OUT OF THE FOOT POCKET AND THE TABS WERE BENT AND UNDISTURBED. THE POSTERIOR NEEDLE WAS BENT NEAR THE FOLLOWER AND THERE WAS A NEEDLE STRIKE MARK ON THE POSTERIOR FOOT. A PROXY PLUNGER WAS INSERTED AND THE NEEDLE TRAJECTORY WAS ACCEPTABLE. BECAUSE LAB TESTING OF THE DEVICE RESULTED IN ACCEPTABLE NEEDLE TRAJECTORY, THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR 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 AS EVIDENCED BY THE NEEDLE STRIKE MARK ON THE POSTERIOR FOOT AND THE BENT ON THE POSTERIOR NEEDLE. 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 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 930396H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention