BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST WITH ECHO

    MDR report key: 3893519 · Received February 14, 2014

    Report

    Report Number
    1213643-2014-00035
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 20, 2014
    Manufacturer
    DAVOL INC SUB C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K110820
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MESH AND ECHO PS WERE RETURNED FOR EVALUATION. BASED ON THE SAMPLE EVALUATION IT IS CONFIRMED THAT THE NEEDLE LOOP COMPLEX WAS FOUND TO HAVE A BROKEN LOOP AND THE INFLATION TUBE WAS BROKEN. ALSO THE EVALUATION OF THE RETURNED PORTION OF THE DEVICE FOUND NO ANOMALIES. THE LOOP OF THE NEEDLE LOOP COMPLEX BEING BROKEN SUGGESTS SIGNIFICANT FORCE WAS APPLIED IN THE EFFORT TO PULL THE ANCHOR OUT OF THE PT'S ABDOMINAL CAVITY. THE CAUSE OF THE RESISTANCE IS UNK AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED AND THERE WERE NO NONCONFORMANCE ISSUES FOUND. THE PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED TO STOCK. AT THIS TIME A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE USER FACILITY: IT WAS ALLEGED THAT ON (B)(6) 2014 DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR IN WHICH A VENTRALIGHT ST WITH ECHO WAS USED, THAT ONCE THE MESH WAS DEPLOYED AND PRIOR TO INFLATING THE BALLOON, THE INSUFFLATION TUBE BROKE. REPORTEDLY, A SUTURE PASSER WAS BEING USED AND WHEN THE SURGEON GRASPED THE INFLATION TUBING BY THE RETRIEVAL LOOP THE SURGEON FELT SOME RESISTANCE. IT WAS REPORTED THAT THE INFLATION TUBE WAS NOT PULLED THROUGH THE UMBILICUS, NOR DID THE SURGEON PRE-STITCH THE DEFECT PRIOR TO PULLING THROUGH. THE MESH WAS REMOVED AND REPLACED WITH ANOTHER ONE. THERE WAS NO HARM OR SIGNIFICANT DELAY TO THE PT. ALL PIECES WERE REMOVED FORM THE PT AND NO SURGICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS SITUATION. THE EVENT AS REPORTED CREATED THE POTENTIAL FOR ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE BROKEN PORTION OF THE DEVICE, AS SUCH AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99245 VENTRALIGHT ST WITH ECHO FTL DAVOL INC SUB C.R. BARD, INC. NA HUXJ1654

    Patients

    Seq Age Sex Outcome Treatment
    1