BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERAL INDWELLING CATHETER/STENT

    MDR report key: 1873394 · Received October 19, 2010

    Report

    Report Number
    3005099803-2010-04365
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED CONTOUR VL STENT REVEALED THE DEVICE WAS CALCIFIED. CALCIFIED RESIDUE WAS VISIBLE IN THE ID OF THE STENT. A .035¿ GUIDEWIRE WOULD NOT PASS THROUGH THE STENT. THE DIRECTIONS FOR USE (DFU) RECOMMENDS PERIODIC RADIOGRAPHIC, ISOTOPIC, OR CYSTOSCOPIC EXAMINATIONS TO EVALUATE STENT EFFICIENCY AND TO OBSERVE FOR POSSIBLE COMPLICATIONS. THIS IS BECAUSE A PATIENT¿S ANATOMY OR PHYSIOLOGY MAY IMPACT STENT PERFORMANCE. IT APPEARS THAT THE STENT BECAME ENCRUSTED DURING INDWELL DUE TO INTERACTION WITH THE PATIENT'S ANATOMY. IT IS MOST LIKELY THAT THE CALCIFICATION ON THE DEVICE CAUSED RESISTANCE WHEN AN ATTEMPT WAS MADE TO REMOVE THE STENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS IMPLANTED IN A PATIENT ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN REPORTED DIFFICULTY REMOVING THE STENT 3 WEEKS POST IMPLANTATION. MEDICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT CONDITION IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS IMPLANTED IN A PATIENT ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN REPORTED DIFFICULTY REMOVING THE STENT 3 WEEKS POST IMPLANTATION. MEDICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT CONDITION IS UNAVAILABLE.

    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