BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2000627 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01139
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 29, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WHOLE MONOFILAMENT WAS RETURNED LOOSE AND INTACT, AND THERE WAS NO SIGN OF BREAKAGE AS REPORTED. BOTH CUFFS WERE STILL ATTACHED TO THE LINK AND RESPECTIVE NEEDLE TIPS. THERE WAS ABOUT 1/4 INCHES OF MONOFILAMENT STILL ATTACHED TO THE NEEDLE TIP AND THE MONOFILAMENT WAS CLEAN CUT. THE CONDITION OF THE RETURNED DEVICE IS NOT CONSISTENT WITH THE COMPLAINT DESCRIPTION. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE WAS DEPLOYED SUCCESSFULLY; THEREFORE THE ROOT CAUSE IS UNDETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNTRAINED PHYSICIAN USING A PROGLIDE DEVICE ATTEMPTED CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SUTURE BROKE WHEN DEPLOYING. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. BED REST WAS INCREASED BY TWO HOURS. 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 760536H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention