BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGICAL BALLOON DILATATION CATHETER

    MDR report key: 1944427 · Received January 3, 2011

    Report

    Report Number
    3005099803-2010-05288
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UROMAX ULTRA DILATATION BALLOON CATHETER KIT WAS RECEIVED INSIDE A FOIL POUCH. A VISUAL AND TACTILE EXAMINATION OF THE POUCH CONTAINING THE DEVICE REVEALED A LARGE TEAR 10MM BELOW THE LABEL, MEASURING 70MM ACROSS. THE TEAR HAD PENETRATED THROUGH THE POUCH, COMPROMISING THE STERILITY OF THE PACKAGE. NO OTHER DEFECTS WERE NOTED WITH THE POUCH, AND NO DAMAGE WAS NOTED TO THE DEVICE. THE EXACT CAUSE OF THE TEAR IS UNKNOWN. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE HANDLING DAMAGE WITHOUT PATIENT CONTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING OF A UROMAX ULTRA DILATATION BALLOON CATHETER KIT, A TEAR WAS NOTICED IN THE PACKAGING COMPROMISING THE STERILE BARRIER. NO VISIBLE DAMAGE WAS NOTICED TO THE OUTER SHIPPING BOX. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING OF A UROMAX ULTRA DILATATION BALLOON CATHETER KIT, A TEAR WAS NOTICED IN THE PACKAGING COMPROMISING THE STERILE BARRIER. NO VISIBLE DAMAGE WAS NOTICED TO THE OUTER SHIPPING BOX. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROLOGICAL BALLOON DILATATION CATHETER DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251370 0013908229

    Patients

    Seq Age Sex Outcome Treatment
    1