BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAVEEN 10CC INFLATOR

    MDR report key: 2062812 · Received April 8, 2011

    Report

    Report Number
    2062812
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC, CORPORATE HEADQUARTERS
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(4): LEFT RENAL STONE. PROCEDURE: LEFT PERCUTANEOUS RENAL ACCESS FOR DILATION OF TRACT CYSTOURETHROSCOPY. RETROGRADE PYELOGRAPHY. LEFT PERCUTANEOUS NEPHROLITHOTOMY OF 1.5 CM STONE. ANTEGRADE STENT AND NEPHROSTOMY TUBE PLACEMENT. INFLATOR SYRINGE FOR UROLOGY BALLOON BROKE DURING ASSEMBLY, UNABLE TO LOCATE ANOTHER, USED SMALLER UROLOGY SYRINGE PUMP THEN VASCULAR SYRINGE (SAME MANUFACTURER) THOUGH SMALLER VOLUME, ADDED EXTRA 10 MINUTES TO PROCEDURE WHILE UNABLE TO PROCEED. DURING DILATION OF THE BALLOON, THE DILATION SYRINGE FRACTURED; THEREFORE, BALLOON COULD NOT BE FULLY INFLATED. ACCORDING TO THE VENDOR, THIS HAS HAPPENED ACROSS THE COUNTRY. THEY ARE REPLACING THEM WITH REVISED PRODUCT. HE WILL ENSURE WE RECEIVE A SHIPMENT OF THE NEW PRODUCT. THEY NO LONGER MANUFACTURE THE DEFECTIVE ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAVEEN 10CC INFLATOR NONE MAV BOSTON SCIENTIFIC, CORPORATE HEADQUARTERS M006710111 UNK-DISCARDED PKG.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention