BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERAL INDWELLING CATHETER/STENT

    MDR report key: 2183034 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02426
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED CONTOUR VL URETERAL STENT REVEALED THAT THE STENT WAS TORN, INSIDE THE PATIENT, BETWEEN THE SUTURE HOLES ON THE PROXIMAL END. THE SUTURE WAS PRESENT WITH THE RETURN. THE INVESTIGATION HAS DETERMINED THAT THE TEAR IS CONSISTENT WITH THOSE CAUSED BY THE SUTURE. MOST LIKELY, WHILE ATTEMPTING TO PLACE THE STENT RESISTANCE WAS MET AND CAUSED THE PROXIMAL END OF THE STENT TO BECOME COMPRESSED BY THE POSITIONER. THE SUTURE MAY HAVE BEEN PULLED THROUGH THE STENT WHILE TRYING TO MANEUVER THE STENT DURING PLACEMENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT "BUNCHED" AND WOULD NOT ADVANCE OVER THE GUIDEWIRE, INSIDE THE PATIENT DURING A URETEROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "FINE." NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR REPORTABLE SCENARIO; HOWEVER, EVALUATION OF THE RETURNED DEVICE REVEALED AN MDR-REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETERAL INDWELLING CATHETER/STENT STENT, URETERAL FAD BOSTON SCIENTIFIC - SPENCER M0061801560

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR