BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC V-18 CONTROL WIRE

    MDR report key: 1801841 · Received August 16, 2010

    Report

    Report Number
    2134265-2010-03834
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE ANALYZED 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

    SAME CASE AS MANUFACTURER REPORT #: 2134265-2010-03794. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE GUIDE WIRE ADHERED TO THE BALLOON CATHETER. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL IN THE LEFT UPPER ARM. A V-18 POLY TIP GUIDE WIRE WAS ADVANCED ACROSS THE LESION. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER MANUFACTURERS BALLOON CATHETER OVER THE WIRE, HOWEVER, THE BALLOON BECAME STUCK ON THE WIRE AND BOTH DEVICES WERE REMOVED AS A UNIT. THE PHYSICIAN SEPARATED THE TWO DEVICES, FLUSHED THE GUIDE WIRE AND ADVANCED THE WIRE ACROSS THE LESION. THE SAME BALLOON WAS ADVANCE OVER THE WIRE, HOWEVER, THE BALLOON BECAME STUCK ON THE WIRE. THE PHYSICIAN REMOVED BOTH DEVICES TOGETHER AS A UNIT AND SEPARATED THE V-18 AND THE BALLOON. A NEW V-18 GUIDE WIRE WAS ADVANCED ACROSS THE LESION. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SAME BALLOON OVER THE GUIDE WIRE, HOWEVER, THE BALLOON BECAME STUCK ON THE MID SECTION OF THE GUIDE WIRE. BOTH DEVICES WERE REMOVED FROM THE PATIENT, AND THE PHYSICIAN SEPARATED THE TWO DEVICES. ANOTHER MANUFACTURERS GUIDE WIRE WAS ADVANCED ACROSS THE LESION AND THE SAME BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC V-18 CONTROL WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI M001468480 13000375

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: EVEREST| INTRODUCER SHEATH: TERUMO| BALLOON CATHETER: KANEKA| BALLOON CATHETER: SHIRANUI HP 5-40| GUIDE WIRE: V-18