BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBICON? 14

    MDR report key: 3201138 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04418
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K112303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION TREATMENT PROCEDURE, THE CATHETER BECAME FROZEN ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. A VICTORY GUIDE WIRE AND A .018 RUBICON SUPPORT CATHETER WERE SELECTED; HOWEVER, WHILE THE PHYSICIAN WAS PLACING THE GUIDE WIRE INSIDE THE SUPPORT CATHETER THE GUIDE WIRE WAS UNABLE TO ADVANCE THROUGH AND BECAME STUCK INSIDE THE 0.18 RUBICON. BOTH DEVICES WERE REMOVED AS A UNIT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303378 RUBICON? 14 CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE UNK730

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: VICTORY WIRE