BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN ENDED URETERAL CATHETER

    MDR report key: 1904729 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04882
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GBM
    PMA / PMN Number
    K830840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THERE WAS 26.2CM OF THE PROXIMAL END OF THE CATHETER STILL ATTACHED, AND THE CAP AND LUER WERE STILL IN PLACE. ONLY 26.3CM OF THE DISTAL END OF THE CATHETER WAS TORN OFF AND RETURNED FOR EVALUATION. SLIGHT INDENTATIONS WERE NOTED IN MULTIPLE PLACES INCLUDING JUST PROXIMAL TO THE TEAR IN THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AXXCESS URETERAL CATHETER WAS USED DURING A URETER DIAGNOSIS PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, DURING THE URETEROGRAPHY, THE CATHETER WAS BROKEN INTO THREE PIECES. NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AXXCESS URETERAL CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AXXCESS URETERAL CATHETER WAS USED DURING A URETER DIAGNOSIS PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, DURING THE URETEROGRAPHY, THE CATHETER WAS BROKEN INTO THREE PIECES. NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AXXCESS URETERAL CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN ENDED URETERAL CATHETER CATHETER, URETHRAL GBM BOSTON SCIENTIFIC - SPENCER M0064001161

    Patients

    Seq Age Sex Outcome Treatment
    1