BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR VL?

    MDR report key: 3210396 · Received July 8, 2013

    Report

    Report Number
    3005099803-2013-05842
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT AND SENSOR PTFE-NITINOL GUIDEWIRE WERE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE SURGEON HAD DIFFICULTY PUSHING THE CONTOUR STENT ON THE SENSOR WIRE UP INTO THE PATIENT'S URETER. THE PHYSICIAN PULLED THE STENT AND THE SENSOR WIRE OUT OF THE PATIENT AND DISCOVERED THAT THE SENSOR WIRE HAD EXITED THROUGH ONE OF THE DRAINAGE HOLES ON THE PROXIMAL END OF THE STENT. THE STENT HAD SPLIT FROM DRAINAGE HOLE TO THE END OF THE STENT AND PART OF THE SENSOR WIRE HAD STRIPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CONTOUR VL URETERAL STENT AND SENSOR PTFE-NITINOL GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2013-05625 FOR THE OTHER ASSOCIATED DEVICE INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311150 CONTOUR VL? STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061801560

    Patients

    Seq Age Sex Outcome Treatment
    1