BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALIGN R RETROPUBIC URETHRAL SUPPORT SYSTEM

    MDR report key: 2094103 · Received May 11, 2011

    Report

    Report Number
    1018233-2011-00099
    Event Type
    Other
    Date Received
    May 11, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 12, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. BASED UPON INFORMATION PROVIDED BY THE USER FACILITY, IMPROPER PROCEDURAL TECHNIQUE BY RESIDENTS MAY HAVE CONTRIBUTED TO REPORTED EVENT. THE INSTRUCTIONS FOR USE PROVIDED WITH THE DEVICES CURRENTLY ADDRESSES PROPER IMPLANT PLACEMENT. THE INTRODUCER INSERTION AND IMPLANT PLACEMENT SECTION STATES: "ATTACH THE CONNECTOR TO THE DISTAL END OF THE INTRODUCER NEEDLE. DETECTABLE FEEDBACK OF THE CONNECTION WILL ALERT THE PHYSICIAN THAT THE CONNECTOR HAS BEEN PROPERLY ENGAGED. GRASP THE INTRODUCER NEEDLE AND DRAW THE IMPLANT UP THROUGH THE ABDOMINAL INCISION UNTIL THE BEGINNING OF THE GREEN GUIDE TUBE CAN BE VISUALIZED THROUGH THE ABDOMINAL INCISION. THE TWO ENDS OF THE GREEN GUIDE TUBE ARE USED TO DRAW THE MESH WITHIN THE PROTECTIVE SHEATH INTO POSITION, PLACING THE GREEN MID-POINT TAB LOOSELY UNDER THE MID-URETHRA. THE GREEN GUIDE TUBE MAY BE CUT WITH SCISSORS OR THE CONNECTOR CAN BE DETACHED FROM THE INTRODUCER OR MAY BE LEFT ATTACHED IF DESIRED." IT ALSO STATES IN THE PRECAUTION SECTION, "THE IMPLANT PROCEDURE REQUIRES DILIGENT ATTENTION TO ANATOMICAL STRUCTURE AND CARE TO AVOID PUNCTURE OF LARGE VESSELS, NERVES, BLADDER, AND ANY VISCERA, DURING INTRODUCER NEEDLE PASSAGE." (B)(4). THIS MDR IS FOR 2 OF 2 OF THE REPORTED PRODUCT FAILURES THAT OCCURRED DURING THE SAME PROCEDURE. PLEASE SEE MDR REPORT #1018233-2011-00098.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO VAGINAL SLING DEVICES BROKE DURING PLACEMENT BY RESIDENTS BEING TRAINED ON THE PROCEDURE. ON THE FIRST PLACEMENT WHILE TRYING TO PULL THE MESH THROUGH, THE PLASTIC CONNECTOR SPLIT. THE DEVICE WAS REMOVED AND A SECOND DEVICE WAS PLACED. AS THE SECOND DEVICE WAS BEING PULLED THROUGH ON THE RIGHT SIDE, THE PLASTIC CONNECTOR SPLIT AGAIN. A THIRD DEVICE WAS SUCCESSFULLY PLACED WITHOUT DIFFICULTY BY AN EXPERIENCED PHYSICIAN. A LACERATION WAS REPAIRED ON THE RIGHT SIDE OF THE BLADDER WHERE THE TROCAR HAD BEEN PLACED THREE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN R RETROPUBIC URETHRAL SUPPORT SYSTEM FTL C.R. BARD, INC. NA HUUE0890

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention