BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LYNX SYSTEM

    MDR report key: 2133853 · Received June 20, 2011

    Report

    Report Number
    3005099803-2011-02126
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MESH ASSEMBLY WAS RETURNED WITH BOTH DILATORS SEPARATED FROM THE MESH SLEEVE. ONLY THE MESH ASSEMBLY WAS RETURNED. VISUAL EXAMINATION OF RETURNED DEVICE REVEALED THAT ONE DILATOR HAD A PORTION OF THE MESH SLEEVE BONDED TO IT. THE SLEEVE MATERIAL WAS STRETCHED, INDICATING THAT A FORCE GREATER THAN THE MINIMUM DRAWING REQUIREMENT OF 4 LB-F WAS APPLIED. THE OTHER DILATOR HAD BEEN CUT FROM THE MESH SLEEVE. OPERATIONAL CONTEXT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MIDURETHRAL SLING SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER (B)(6). ACCORDING TO THE COMPLAINANT, ONE OF THE BLUE DILATORS AND ASSOCIATION LOOPS DETACHED FROM THE MESH ASSEMBLY WHILE THE PHYSICIAN WAS PULLING THE MESH SLEEVE THROUGH THE TISSUE. THIS OCCURRED ON THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT THE DILATOR RIPPED COMPLETELY OFF THE PLASTIC MESH SLEEVE, BUT THAT IT DID NOT DETACH INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER LYNX SLING SYSTEM WITHOUT ANY PATIENT COMPLICATIONS. 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 SUPRAPUBIC MIDURETHRAL SLING SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE (B)(6). ACCORDING TO THE COMPLAINANT, ONE OF THE BLUE DILATORS AND ASSOCIATION LOOPS DETACHED FROM THE MESH ASSEMBLY WHILE THE PHYSICIAN WAS PULLING THE MESH SLEEVE THROUGH THE TISSUE. THIS OCCURRED ON THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT THE DILATOR RIPPED COMPLETELY OFF THE PLASTIC MESH SLEEVE, BUT THAT IT DID NOT DETACH INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER LYNX SLING SYSTEM WITHOUT ANY PATIENT COMPLICATIONS. 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 M0068503000

    Patients

    Seq Age Sex Outcome Treatment
    1