BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBICON? 14

    MDR report key: 3935571 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04291
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K112303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE GUIDEWIRE BECAME STUCK IN THE CATHETER. THE PHYSICIAN WAS USING A CROSSOVER APPROACH, THE 150CM RUBICON 14 SUPPORTING CATHETER WAS ADVANCED OVER A 300CM VICTORY 14 GUIDEWIRE FROM LEFT FEMORAL ARTERY THROUGH THE COOK¿S 6F 45CM LONG SHEATH TO THE RIGHT SFA TO PROVIDE MORE SUPPORT TO THE GUIDEWIRE FOR CHRONIC TOTAL OCCLUSION (CTO) PENETRATION. DURING ADVANCEMENT OF THE RUBICON CATHETER OVER THE VICTORY GUIDEWIRE, THE DEVICE GOT STUCK APPROXIMATELY 20-30MM FROM THE DISTAL END OF THE VICTORY GUIDEWIRE. THE VICTORY WIRE COULD NOT BE ADVANCED NOR WITHDRAWN. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. OUTSIDE THE BODY, RESISTANCE WAS STILL ENCOUNTERED WHEN TRYING TO REMOVE THE VICTORY WIRE FROM THE RUBICON CATHETER. SUBSEQUENTLY, THE RUBICON CATHETER WAS FLUSHED AND WAS ABLE TO REMOVE THE VICTORY GUIDEWIRE. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. NO COMPLICATIONS WERE REPORTED AND THE PATIENTS¿ STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412160 RUBICON? 14 CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939212014151 16331546

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR