BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-14¿ CONTROLWIRE®

    MDR report key: 5982962 · Received September 28, 2016

    Report

    Report Number
    2134265-2016-08559
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 31, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    DQX
    PMA / PMN Number
    K112745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. THE DEVICE WAS RETURNED FOR ANALYSIS. THE UNIT RETURNED HAS DISTAL END DAMAGE, AS PART OF OVERALL VISUAL REVISION. THE WIRE HAS THE DISTAL TIP DETACHED 1.5 CM APPROX FROM THE DISTAL SECTION END AND IT IS EXPOSING THE CORE WIRE. THE BODY WAS ALSO KINKED IN THE MIDDLE OF THE DEVICE. THE DIMENSIONAL INSPECTION WAS PERFORMED AND WAS FOUND TO BE WITHIN SPECIFICATION. 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

    SAME CASE AS MDR ID: 2134265-2016-08560. IT WAS REPORTED THAT THE GUIDE WIRE COATING PEELED. A V-14(TM) CONTROL WIRE(TM) WAS SELECTED FOR USE DURING AN INTRALUMINAL ANGIOPLASTY PROCEDURE IN THE LOWER LIMBS. ONCE THE V-14(TM) CONTROL WIRE(TM) PASSED THE STENOSIS, A PART OF THE HYDROPHILIC COVER FELL APART AND REMAINS INSIDE THE PATIENT'S ARTERY. THE PHYSICIAN THEN ADVANCED A SECOND V-14(TM) CONTROL WIRE(TM) BUT EXPERIENCED THE SAME PROBLEM. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE ALL PARTS OF THE SECOND GUIDE WIRE FROM THE PATIENT. A DIFFERENT UNSPECIFIED GUIDE WIRE WAS THEN ADVANCED AND WORKED PERFECTLY. BALLOON ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-08560. IT WAS REPORTED THAT THE GUIDE WIRE COATING PEELED. A V-14 CONTROLWIRE WAS SELECTED FOR USE DURING AN INTRALUMINAL ANGIOPLASTY PROCEDURE IN THE LOWER LIMBS. ONCE THE V-14 CONTROLWIRE PASSED THE STENOSIS, A PART OF THE HYDROPHILIC COVER FELL APART AND REMAINS INSIDE THE PATIENT'S ARTERY. THE PHYSICIAN THEN ADVANCED A SECOND V-14 CONTROLWIRE BUT EXPERIENCED THE SAME PROBLEM. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE ALL PARTS OF THE SECOND GUIDE WIRE FROM THE PATIENT. A DIFFERENT UNSPECIFIED GUIDE WIRE WAS THEN ADVANCED AND WORKED PERFECTLY. BALLOON ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635785 V-14¿ CONTROLWIRE® WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H74939216730010 0019215996

    Patients

    Seq Age Sex Outcome Treatment
    1