BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE GUIDEWIRE

    MDR report key: 2061260 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01342
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: DEVICE WAS RECEIVED IN TWO PIECES. THE DEVICE IS FRACTURED 69CM FROM THE PROXIMAL END. THE LENGTH OF THE PROXIMAL SECTION IS 69CM AND DISTAL SECTION IS 113CM. ALL OF THE OUTER DIAMETER MEASUREMENTS WERE MEASURED AND MET SPECIFICATIONS. THE FRACTURED SECTION WAS SENT TO THE SEM LAB FOR ANALYSIS AND THEIR EVALUATION REVEALED THAT THE FRACTURE WAS DUE TO A BENDING OVERLOAD. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED OBTUSE MARGINAL ARTERY. THE PHYSICIAN ADVANCED A CHOICE PT AND NON-BSC GUIDE WIRE TO THE LESION AND THEN ADVANCED A 2.5X12MM APEX BALLOON TO THE LESION AND SUCCESSFULLY COMPLETED DILATION. NO RESISTANCE WAS FELT DURING REMOVAL OF THE BALLOON AND GUIDE WIRE, HOWEVER THE DISTAL PORTION OF THE CHOICE PT GUIDE WIRE BROKE OFF INSIDE THE GUIDE CATHETER. EVERYTHING WAS REMOVED WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CHOICE PT GUIDE WIRE AND THE DEPLOYMENT OF A PROMUS STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED OBTUSE MARGINAL ARTERY. THE PHYSICIAN ADVANCED A CHOICE PT AND NON-BSC GUIDE WIRE TO THE LESION AND THEN ADVANCED A 2.5X12MM APEX BALLOON TO THE LESION AND SUCCESSFULLY COMPLETED DILATION. NO RESISTANCE WAS FELT DURING REMOVAL OF THE BALLOON AND GUIDE WIRE, HOWEVER THE DISTAL PORTION OF THE CHOICE PT GUIDE WIRE BROKE OFF INSIDE THE GUIDE CATHETER. EVERYTHING WAS REMOVED WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CHOICE PT GUIDE WIRE AND THE DEPLOYMENT OF A PROMUS STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74912160012 0014028159

    Patients

    Seq Age Sex Outcome Treatment
    1 WHISPER GUIDE WIRE| APEX BALLOON CATHETER, 2.5X12MM