BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2241112 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06230
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. FOURTEEN STERILE REPRESENTATIVE SAMPLES OF THE PROGLIDE DEVICE FROM THE SAME LOT REPORTED IN THE MANUFACTURER REPORT NUMBERS 2024168-2011-05496, 2024168-2011-05497 AND 2024168-2011-05498 WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING DETECTED THAT ON ONE OF THE DEVICES A POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT OCCURRED DURING THE NEEDLE PLUNGER RETRACTION. THE REMAINING 13 DEVICES PASSED FUNCTIONAL TESTING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    THE FACILITY RETURNED 14 UNUSED STERILE PROGLIDE DEVICES FOR EVALUATION AFTER THE CUSTOMER EXPERIENCED A CUFF MISS/SUTURE RETRIEVAL ISSUE REPORTED AS: "NO SUTURES WERE PRESENT WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. ANALYSIS OF ONE OF THE DEVICES RESULTED IN A CUFF-TO-NEEDLE TIP DETACHMENT DURING THE NEEDLE PLUNGER RETRACTION.

    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 040416H

    Patients

    Seq Age Sex Outcome Treatment
    1