BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2114223 · Received March 24, 2011

    Report

    Report Number
    2183959-2011-00101
    Event Type
    Other
    Date Received
    March 24, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED, BUT HAS NOT BEEN RECEIVED TO-DATE. (B)(4). THEREFORE, NO CORRECTIVE ACTION IS PENDING. THE CONNECTORS ARE MADE FROM POLYCARBONATE MATERIAL. AMS HAS CONDUCTED THE FOLLOWING BIOCOMPATABILITY TESTING ON THE CONNECTOR: CYTOTOXICITY (MEM ELUTION), SENSITIZATION, AND INTRACUTANEOUS IRRITATION. THE CONNECTOR IS CONSIDERED NON-CYTOTOXIC, A NEGLIGIBLE IRRITANT, AND IS CLASSIFIED AS HAVING WEAK ALLERGENIC AND/OR SENSITIZATION POTENTIAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, DURING A MONARC SLING PROCEDURE, "UNUSUALLY HIGH RESISTANCE WAS FELT WHEN PASSING THE NEEDLE THROUGH THE LEFT SIDE." AFTER PASSAGE OF THE NEEDLE THROUGH THE VAGINAL INCISION, UPON NEEDLE PULL BACK, THE PLASTIC TIP CAME OFF THE NEEDLE. THE PLASTIC TIP WAS REATTACHED TO THE NEEDLE THROUGH THE VAGINAL INCISION, AND PULL BACK WAS AGAIN ATTEMPTED THROUGH THE VAGINAL INCISION. THIS TIME THE NEEDLE CAME THROUGH THE INCISION WITHOUT THE SLING ATTACHED. WHEN THE SLING WAS RETRIEVED THROUGH THE VAGINAL INCISION, "THE PLASTIC TIP HAD COME OFF THE PLASTIC SHEATH ENTIRELY AND WAS LOST IN THE LEFT PERI-URETHRAL SPACE (LATERAL TUNNEL). THE SURGEON WAS UNABLE TO FIND THE PLASTIC TIP, EVEN AFTER RE-PASSING THE NEEDLES THROUGH THE TUNNEL." THE PROCEDURE WAS NOT COMPLETED. THE PHYSICIAN WAS ADVISED ON REMOVAL OF THE, "POLYCARBONATE TIP INSIDE THE PATIENT, INCLUDING X-RAY AND ULTRASOUND TO ASSIST IN LOCATION OF IT." THE SURGEON CHOSE NOT TO FOLLOW THE ADVICE. INSTEAD, HE CHOSE TO ADMIT THE PATIENT OVERNIGHT AND REPORTED THAT SHE HAD NO PAIN AND THAT HE HAD CHOSEN TO LEAVE THE PLASTIC TIP INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O