BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATATION CATHETER, BALLOON

    MDR report key: 2994280 · Received March 8, 2013

    Report

    Report Number
    3005099803-2013-01130
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LJE
    PMA / PMN Number
    K952968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR A PCNL PROCEDURE, WHEN THE NEPHROMAX DEVICE WAS UNPACKED, THE LABEL OF THE DEVICE WAS NOTICED TO READ A 30FR SIZE, BUT THE DEVICE APPEARED TO BE A 24FR SIZE. REPORTEDLY, THE PHYSICIAN BELIEVED BOTH THE BALLOON AND SHEATH APPEARED SMALLER THAN WHAT WAS LABELED ON THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, WITH NO COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100173 DILATATION CATHETER, BALLOON CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC - GALWAY UNK265

    Patients

    Seq Age Sex Outcome Treatment
    1