BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 4122955 · Received September 26, 2014

    Report

    Report Number
    3005099803-2014-03156
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    February 7, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO SYSTEM WAS USED DURING A TRANSOBTURATOR TAPE PROCEDURE PERFORMED ON (B)(6), 2014. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO COMPLICATIONS REPORTED IMMEDIATELY AT THE CONCLUSION OF THE PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT DEVELOP EROSION AFTER DEVICE IMPLANTATION. THE ERODED PART OF THE SLING WAS REMOVED. LATER, THE PATIENT EXPERIENCED URINARY RETENTION. CYSTOSCOPY RESULTS REVEALED THAT THE SLING WAS TIGHT/ TENSIONED AROUND THE URETHRA BUT NOT ERODED INTO THE MUCOSAL. THE PHYSICIAN DECIDED TO REMOVE THE ENTIRE SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600828 OBTRYX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC - MARLBOROUGH M0068505001 ML00001746

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention