BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROURETERAL STENT SYSTEM

    MDR report key: 2083566 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01675
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FAD
    PMA / PMN Number
    K860267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RESIDUE WAS PRESENT IN THE DEVICE TO INDICATE USE. FROM A VISUAL EVALUATION, IT WAS FOUND THAT THE PROXIMAL HUB SECTION OF THE CATHETER-STENT HAD BEEN CUT OFF WITH THE SUTURE AND THE HUB SECTION WITH THE REMAINING SUTURE/ STOP COCK KEY WAS NOT RETURNED. THE METAL CANNULA WAS ALSO NOT RETURNED WITH THE DEVICE. THE TIP OF THE STENT WAS INTACT. EXAMINING THE TIP, THE METAL SLEEVE WHICH IS ATTACHED TO THE DISTAL END OF THE METAL CANNULA, WAS FOUND DETACHED AND LOCATED AT THE TIP OF THE CATHETER. THE METAL SLEEVE WAS PUSHED FROM THE TIP OF THE CATHETER TO THE DRAINAGE HOLE SECTION. THE CATHETER WAS THEN CUT OPEN TO REMOVE THE METAL SLEEVE. THE RETRIEVED METAL SLEEVE WAS FOUND COVERED IN RESIDUE/ PATIENT BODY FLUIDS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS DRAINAGE PROCEDURE THE METAL TIP OF THE STIFFENER BROKE. IT WAS STATED THAT THE TIP OF THE METAL STIFFENER CAME OFF AND REMAINED IN THE CATHETER. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS DRAINAGE PROCEDURE THE METAL TIP OF THE STIFFENER BROKE. IT WAS STATED THAT THE TIP OF THE METAL STIFFENER CAME OFF AND REMAINED IN THE CATHETER. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPHROURETERAL STENT SYSTEM STENT, URETERAL FAD BOSTON SCIENTIFIC - SPENCER M001221410 13259852

    Patients

    Seq Age Sex Outcome Treatment
    1