BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM

    MDR report key: 441732 · Received February 6, 2003

    Report

    Report Number
    6000043-2003-00012
    Event Type
    Injury
    Date Received
    February 6, 2003
    Date of Event
    December 17, 2002
    Report Date
    January 8, 2003
    Manufacturer
    MICROVASIVE UROLOGY, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO SEAT AN ANCHOR FOR PLACEMENT OF A SLING FOR TREATMENT OF INCONTINENCE AFTER COMPLETION OF A VAGINAL HYSTERECTOMY, THE PHYSICIAN PULLED THE TRIGGER TO SEAT THE ANCHOR AND CLOCKWISE TIGHTENING MOTION OCCURRED. HOWEVER, WHEN THE DOCTOR RELEASED THE TRIGGER, THERE WAS RECOIL MOTION AND THE ANCHOR WOULDN'T SEAT. THIS OCCURRED WITH THREE SEPARATE DEVICES AND THE DOCTOR WASN'T ABLE TO SEAT ANY ANCHORS. THE DOCTOR THEN DECIDED TO COMPLETE THE PROCEDURE PERCUTANEOUSLY USING STAMEY NEEDLES, PROLENE SUTURES AND THE REPLIFORM SLING THEY HAD PLANNED TO USE WITH THE PRECISION TWIST DEVICE. THIS DEVICE HAS BEEN RECEIVED, EVALUATED AND RETAINED BY THIS MANUFACTURER. TWO OTHER DEVICES WERE USED IN THIS PROCEDURE. PLEASE REFERENCE MEDWATCH 6000043-2003-00010 AND 6000043-2003-00011. IT WAS NOT DETERMINED WHICH BATCH NUMBER RELATED TO EACH DEVICE. NO DAMAGE TO THE DRIVER WAS FOUND. THE SUTURE WAS TWISTED AND RUPTURED APPROXIMATELY 1 CM FROM THE ANCHOR STEM. THE REST OF THE SUTURE/ANCHOR SYSTEM ASSEMBLY WAS NOT RETURNED. CO BELIEVES USER TECHNIQUE, AND/OR PATIENT ANATOMY MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, CO IS UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "THE RISKS ASSOCIATED WITH PROCEDURES THAT REQUIRE PLACEMENT OF A BONE ANCHOR CAN BE GREATER IN PATIENTS WITH CHRONIC CONDITIONS SUCH AS... OBESITY... PATIENTS WITH THESE CONDITIONS OR ANY OTHER CONDITIONS WHICH MAY AFFECT INTRAOPERATIVE TECHNIQUE...MUST BE CAREFULLY EVALUATED TO DETERMINE THE RELATIVE RISKS AND BENEFITS OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM TRANSVAGINAL ANCHOR SYSTEM MBI MICROVASIVE UROLOGY, A DIVISION OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention