BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERAL CATHETER

    MDR report key: 2896898 · Received January 4, 2013

    Report

    Report Number
    3005099803-2012-06433
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GBM
    PMA / PMN Number
    K830840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF DEVICE CATHETER BENT. VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THERE WAS A SECTION ON THE PROXIMAL END WHERE THE OUTER DIAMETER WAS SMALLER. THIS IS WHERE THE CONNECTOR HAD BEEN TIGHTENED DOWN. THE CONNECTOR WAS NOT RETURNED. THE CATHETER WAS BROKEN INTO TWO FRAGMENTS. THE DISTAL FRAGMENT MEASURED APPROXIMATELY 25.7CM AND THE PROXIMAL END MEASURED APPROXIMATELY 43.2CM LONG. THE CATHETER WAS KINKED AND BENT IN SEVERAL LOCATIONS. A FUNCTIONAL EVALUATION WAS PERFORMED AND A .038' GUIDEWIRE WAS INSERTED INTO BOTH FRAGMENTS. THE GUIDEWIRE PASSED FREELY THROUGH EACH. THE MATERIAL WAS FLEXED AND DID NOT APPEAR TO BE BRITTLE; IT WOULD NOT BREAK. THE ROOT CAUSE IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF DEVICE CATHETER BREAK.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE COMPLAINANT REVEALED THAT THE CATHETER BROKE IN HALF WHEN HELD IN A TIGHT CIRCULAR FASHION BY THE SURGEON. THE MIDDLE OF THE 5 FRENCH SHAFT IS THE PART OF THE CATHETER THAT BROKE. THERE WAS NO RESISTANCE MET BEFORE THE URETERAL CATHETER BREAKAGE AND NO OTHER CONTRIBUTING FACTORS. NO PIECES FELL INTO THE PATIENT. THE SCOPE WAS NOT DAMAGED DUE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A URETERAL CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER BROKE AND WAS PARTIALLY STICKING OUT OF THE URETEROSCOPE. THE PROBLEM OCCURRED OUTSIDE THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO HARM TO THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4836 URETERAL CATHETER CATHETER, URETHRAL GBM BOSTON SCIENTIFIC - SPENCER M0064002011 15553606

    Patients

    Seq Age Sex Outcome Treatment
    1