BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2141633 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02226
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: LOT NUMBER; INITIALLY REPORTED: 1ML1010301.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A SLING PROCEDURE. THE PATIENT'S AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MESH CARRIER INADVERTENTLY RELEASED FROM THE DELIVERY DEVICE TIP BEFORE THE PHYSICIAN DEPLOYED THE DEVICE TO IMPLANT THE CARRIER. THIS OCCURRED ON THE FIRST SIDE OF IMPLANTATION WHICH WAS THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT THE CARRIER WAS FULLY SEATED ON THE DELIVERY DEVICE TIP PRIOR TO INSERTION THROUGH THE VAGINAL INCISION AND THAT THE PHYSICIAN WAS NOT HOLDING ONTO THE MESH WHILE ATTEMPTING TO DEPLOY THE DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT'S ANATOMY. THE PHYSICIAN THEN REMOVED THE SLING AND NOTED THAT THE MESH HAD STRETCHED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER SOLYX SLING SYSTEM WITHOUT ANY COMPLICATIONS. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE," HOWEVER, THE PATIENT WAS CATHETERIZED POST PROCEDURE AND IS CURRENTLY IN RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A SLING PROCEDURE. THE PATIENT'S AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MESH CARRIER INADVERTENTLY RELEASED FROM THE DELIVERY DEVICE TIP BEFORE THE PHYSICIAN DEPLOYED THE DEVICE TO IMPLANT THE CARRIER. THIS OCCURRED ON THE FIRST SIDE OF IMPLANTATION WHICH WAS THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT THE CARRIER WAS FULLY SEATED ON THE DELIVERY DEVICE TIP PRIOR TO INSERTION THROUGH THE VAGINAL INCISION AND THAT THE PHYSICIAN WAS NOT HOLDING ONTO THE MESH WHILE ATTEMPTING TO DEPLOY THE DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT'S ANATOMY. THE PHYSICIAN THEN REMOVED THE SLING AND NOTED THAT THE MESH HAD STRETCHED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER SOLYX SLING SYSTEM WITHOUT ANY COMPLICATIONS. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE," HOWEVER, THE PATIENT WAS CATHETERIZED POST PROCEDURE AND IS CURRENTLY IN RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507000 1ML1010301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ANTERIOR AND POSTERIOR REPAIR| HYSTERECTOMY