BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2021556 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00831
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS (B)(6).

    Additional Manufacturer Narrative · 1

    PATIENT WAS OVER 18 YEARS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT. VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED NO DEFECTS ON DELIVERY DEVICE OR ASSOCIATION LOOPS OF THE MESH SLEEVE. THE BLUE CENTERING TAB OF THE MESH SLEEVE WAS MISSING AND THE SLEEVE HAD BEEN SEPARATED INTO TWO PIECES. THE BODY OF THE MESH WAS RECEIVED CUT INTO THREE PIECES AND SEPARATE FROM THE SLEEVE. THINNING AND STRETCHING WAS NOTED ON ONE OF THE THREE PIECES. THE REPORTED EVENT WAS CONFIRMED, HOWEVER, THE ROOT CAUSE WAS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO TRANSOBTURATOR SLING SYSTEM WAS USED DURING A TRANSOBTURATOR TAPE PROCEDURE. THIS IS THE SAME CASE AND PATIENT AS MFR REPORT # 3005099803-2011-00832. THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. ACCORDING TO THE COMPLAINANT, THE SLING WAS PLACED NORMALLY. THE BLUE CENTERING TAB WAS CUT AND THE MESH SLEEVES WERE PULLED OFF. WHEN THE PHYSICIAN THEN ATTEMPTED TO ADJUST THE MESH BY PULLING ON EACH SIDE, THE MESH TORE IN HALF AT THE MIDLINE. THE MESH WAS REMOVED FROM THE PATIENT AND ANOTHER OBTRYX HALO TRANSOBTURATOR SLING SYSTEM WAS OPENED AND PLACED IN THE PATIENT IN THE SAME MANNER AS THE FIRST SLING. THE BLUE CENTERING TAB WAS CUT. WHEN THE PHYSICIAN ATTEMPTED TO ADJUST THE MESH, IT TORE AT THE MIDLINE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD OBTRYX HALO TRANSOBTURATOR SLING SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO TRANSOBTURATOR SLING SYSTEM WAS USED DURING A TRANSOBTURATOR TAPE PROCEDURE. THIS IS THE SAME CASE AND PATIENT AS MFR REPORT # 3005099803-2011-00832. THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. ACCORDING TO THE COMPLAINANT, THE SLING WAS PLACED NORMALLY. THE BLUE CENTERING TAB WAS CUT AND THE MESH SLEEVES WERE PULLED OFF. WHEN THE PHYSICIAN THEN ATTEMPTED TO ADJUST THE MESH BY PULLING ON EACH SIDE, THE MESH TORE IN HALF AT THE MIDLINE. THE MESH WAS REMOVED FROM THE PATIENT AND ANOTHER OBTRYX HALO TRANSOBTURATOR SLING SYSTEM WAS OPENED AND PLACED IN THE PATIENT IN THE SAME MANNER AS THE FIRST SLING. THE BLUE CENTERING TAB WAS CUT. WHEN THE PHYSICIAN ATTEMPTED TO ADJUST THE MESH, IT TORE AT THE MIDLINE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD OBTRYX HALO TRANSOBTURATOR SLING SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000 1ML0092901

    Patients

    Seq Age Sex Outcome Treatment
    1