BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX? II SYSTEM - HALO

    MDR report key: 22299026 · Received June 20, 2025

    Report

    Report Number
    2124215-2025-40194
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    March 24, 2021
    Report Date
    June 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729837565
    PMA / PMN Number
    K121754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: PATIENT CODE E2006 CAPTURES THE REPORTABLE EVENT OF BLADDER EROSION. PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING AT THE END OF THE PROCEDURE. PATIENT CODE E2314 CAPTURES THE REPORTABLE EVENT OF FISTULA. PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. PATIENT CODE E1310 CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. PATIENT CODE E230901 CAPTURES THE REPORTABLE EVENT OF CALCIFICATIONS FOUND. IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF OPENING THE APONEUROSIS OF THE RECTUS SHEATH TO CLOSE THE BLADDER. IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF 2 CYSTO CATH AND URINARY CATHETER THAT HAS BEEN PUT IN PLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OBTRYX II SYSTEM HALO DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PREVIOUS PROCEDURE. SOMETIME AFTER THE PROCEDURE, THERE WAS MESH EROSION INTO THE BLADDER WITH CALCIFICATION ON THE RIGHT SIDE. IT WAS NOTED THAT THE PATIENT UNDERWENT A SURGERY WITH COMPLICATIONS; THERE WAS BLEEDING AT THE END OF THE PROCEDURE, AND THEY HAD TO OPEN THE APONEUROSIS OF THE RECTUS SHEATH TO CLOSE THE BLADDER. THREE WEEKS FOLLOWING THE INTERVENTION, THE PATIENT DEVELOPED A FISTULA, RESULTING IN TWO CATHETERS, A CYSTOCATH AND A URINARY CATHETER, BEING PLACED. SINCE THE INITIAL SYMPTOMS, THE PATIENT CONTINUED EXPERIENCING PAIN AND URINARY TRACT INFECTIONS. IT WAS NOTED THAT PAIN MANAGEMENT ATTEMPTS HAVE NOT BEEN EFFECTIVE. THERE HAVE NOT BEEN ANY REPORTED FURTHER ACTIONS TO MANAGE THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202180 OBTRYX? II SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505110 0023766189 08714729837565

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention