BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2240058 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06213
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    June 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. SIX STERILE REPRESENTATIVE SAMPLES OF PROGLIDE DEVICES FROM THE SAME LOT REPORTED IN MANUFACTURER REPORT NUMBERS 2024168-2011-05212 AND 2024168-2011-05213 WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING DETECTED THAT ON ONE OF THE DEVICES AN ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT OCCURRED DURING NEEDLE PLUNGER RETRACTION. THE REMAINING FIVE 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 SIX UNUSED/STERILE PROGLIDE DEVICES FOR EVALUATION AFTER THE CUSTOMER EXPERIENCED A CUFF MISS/SUTURE RETRIEVAL ISSUE REPORTED AS: "AFTER REMOVING THE NEEDLES, THE PHYSICIAN FOUND THAT THERE WAS NO SUTURE ATTACHED TO THE NEEDLES. THE PHYSICIAN SAID THAT IT FELT AS IF THE NEEDLES WERE NOT HOOKING INTO THE FOOTPLATE CORRECTLY". ANALYSIS OF ONE OF THE DEVICES RESULTED IN AN ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT DURING 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-TEMECULA-CT 950336H

    Patients

    Seq Age Sex Outcome Treatment
    1