BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LYNX SYSTEM

    MDR report key: 1834224 · Received September 14, 2010

    Report

    Report Number
    3005099803-2010-03901
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED NO DEFECTS TO THE DELIVERY DEVICE. THE MESH WAS NOTED TO BE PULLED AND TWISTED, BUT NO CUTS OR TEARS WERE NOTED. ONLY THE MESH, ONE PLASTIC SLEEVE AND ONE DELIVERY DEVICE WERE RETURNED. THE CENTERING TAB WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN INSERTED BOTH SIDES OF THE MESH INTO THE TISSUE. THE PHYSICIAN THEN POSITIONED AND TENSIONED THE MESH ASSEMBLY AND CUT THE BLUE CENTERING TAB. DURING THE REMOVAL OF THE PLASTIC SLEEVES, THE MESH TORE IN HALF NEAR THE CENTERING LINE INTO TWO SEPARATE PIECES. BOTH PIECES OF THE MESH WERE REMOVED FROM THE PATIENT. NO PART OF THE MESH ASSEMBLY WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LYNX SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN INSERTED BOTH SIDES OF THE MESH INTO THE TISSUE. THE PHYSICIAN THEN POSITIONED AND TENSIONED THE MESH ASSEMBLY AND CUT THE BLUE CENTERING TAB. DURING THE REMOVAL OF THE PLASTIC SLEEVES, THE MESH TORE IN HALF NEAR THE CENTERING LINE INTO TWO SEPARATE PIECES. BOTH PIECES OF THE MESH WERE REMOVED FROM THE PATIENT. NO PART OF THE MESH ASSEMBLY WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LYNX SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068503001 1ML0032503

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR