BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA¿

    MDR report key: 3072578 · Received April 23, 2013

    Report

    Report Number
    3005099803-2013-03074
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE NOTED A KINK JUST DISTAL TO THE STRAIN RELIEF. IT WAS POSSIBLE TO INSERT A 0.038 INCH GUIDEWIRE THROUGH THE DEVICE; HOWEVER, SOME RESISTANCE WAS NOTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON WAS USED DURING A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE BALLOON OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER UROMAX ULTRA DEVICE. THE PATIENT WAS FINE POST PROCEDURE WITH NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173596 UROMAX ULTRA¿ DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251010 0015582608

    Patients

    Seq Age Sex Outcome Treatment
    1 44