BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3140571 · Received May 31, 2013

    Report

    Report Number
    3005099803-2013-03968
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR. (B)(6) IMPLANTED THE UPHOLD VAGINAL SUPPORT SYSTEM AND DR. (B)(6), IMPLANTED THE OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM AND PINNACLE POSTERIOR PFR KIT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT LISTED TWO FACILITIES ASSOCIATED WITH THIS COMPLAINT, (B)(6). IT IS UNKNOWN WHICH FACILITY THE DEVICE WAS IMPLANTED AT. THE COMPLAINANT ALSO LISTED THE FOLLOWING PHYSICIAN¿S ASSOCIATED WITH THIS COMPLAINT: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN, THE PATIENT PRESENTED SOME EROSION AT THE SUTURE LINE. THE MESH APPEARED TO BE BUNCHED AT THE CERVIX. THE MESH WAS REMOVED AND THE PHYSICIAN PERFORMED A HYSTERECTOMY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2013-04640 PERTAINS TO THE OTHER DEVICE. RECEIVED THE FOLLOWING EVENT CLARIFICATION FROM THE PHYSICIAN: THE MESH THAT HAD ERODED AT THE SUTURE LINE AND ALSO BUNCHED AT THE CERVIX WAS FROM AN UPHOLD VAGINAL SUPPORT SYSTEM IMPLANTED ON (B)(6) 2011. ON (B)(6) 2012, THE UPHOLD DEVICE WAS EXPLANTED, THE PATIENT HAD A HYSTERECTOMY AND A PROLAPSE REPAIR, AND THE OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM AND PINNACLE POSTERIOR PFR KIT WERE IMPLANTED. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240811 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PINNACLE POSTERIOR PFR KIT