BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGICAL BALLOON DILATATION CATHETER

    MDR report key: 1935941 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05163
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    August 31, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAXULTRA BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON STARTED TO LEAK. A HOLE IN THE BALLOON WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, AFTER THE UROMAX ULTRA BALLOON WAS PLACED, IT WAS ABLE TO BE PARTIALLY INFLATED WITH A MEDIUM OF 50/50 SALINE AND CONTRAST. A LEVEEN INFLATOR WAS USED AND THE BALLOON WAS NOT TESTED PRIOR TO INSERTION. IT WAS REPORTED THAT THE BALLOON DID NOT RUPTURE AND NO PIECES DETACHED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROLOGICAL BALLOON DILATATION CATHETER DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251220 13453262

    Patients

    Seq Age Sex Outcome Treatment
    1