BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE? PT

    MDR report key: 3091363 · Received May 3, 2013

    Report

    Report Number
    2134265-2013-03142
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ONE DEVICE WAS RECEIVED IN TWO SEGMENTS WITH ITS ORIGINAL POUCH. AFTER VISUAL INSPECTION BEFORE DECONTAMINATION PROCESS, DEVICE PRESENTS THE BODY BENT. VISUAL INSPECTION WAS PERFORMED. THE DEVICE RETURNED IN TWO SECTIONS: THE PART#1 (PROXIMAL); AND PART #2 (DISTAL) IS KINKED AND BENT ALONG THE BODY. MEASUREMENTS WERE TAKEN WITH A RULER. DIMENSIONAL INSPECTION WAS DONE AND ALL OF THEM ARE ACCORDING TO SPECIFICATIONS. BOSTON SCIENTIFIC MANUFACTURING PROCESSES INCLUDE EXTENSIVE INSPECTIONS TO ENSURE THAT ALL FINISHED DEVICES MEET SPECIFICATIONS. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS ((B)(4)) TO DETERMINE THE FRACTURE FAILURE MODE. THE (B)(4) RETURNED THE FOLLOWING RESULTS: FAILURE OCCURRED DUE TO A FATIGUE EVENT IN A BENDING MOMENT FOLLOWED BY A FINAL TENSION 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 PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION IS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5 X 15 MM QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED OVER THE CHOICE PT ES GUIDE WIRE AND THE BALLOON WAS INFLATED TO DILATE THE LESION. AS THEY WERE WITHDRAWING THE CATHETER, IT WAS NOTED THAT THE CHOICE PT ES GUIDE WIRE WAS FRACTURED ABOUT 12-14 INCHES FROM THE END PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER CHOICE PT ES GUIDE WIRE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION IS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5 X 15 MM QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED OVER THE CHOICE PT ES GUIDE WIRE AND THE BALLOON WAS INFLATED TO DILATE THE LESION. AS THEY WERE WITHDRAWING THE CATHETER, IT WAS NOTED THAT THE CHOICE PT ES GUIDE WIRE WAS FRACTURED ABOUT 12-14 INCHES FROM THE END PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER CHOICE PT ES GUIDE WIRE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194802 CHOICE? PT WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H74912161011

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR