BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ MARKER GUIDE WIRE

    MDR report key: 2123180 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02188
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K040140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE REVEALED AN ELONGATED DISTAL TIP. APPROXIMATELY 2MM OF THE SPRING TIP IS ELONGATED. ALL OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. X-RAY ANALYSIS OF THE DEVICE REVEALED THE RADIOPAQUE MARKER MET SPECIFICATION. THE DEFECT NOTED IN THE INITIAL REPORT MAY BE THE DISTAL TIP SOLDER AND THE INNER COIL WHICH ARE NOT ATTACHED BY DESIGN. 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 CORONARY INTERVENTION, THE GUIDE WIRE FRACTURED. THE 75-80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE IQ MARKER GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT ISSUE. WHILE POSITIONING THE GUIDE WIRE UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THAT A PORTION OF THE RADIOPAQUE TIP WAS NOT VISIBLE. THE PHYSICIAN FELT THE DEVICE HAD FRACTURED AND OPTED TO REMOVE IT. THE WIRE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER IQ MARKER GUIDE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE GUIDE WIRE FRACTURED. THE 75-80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE IQ MARKER GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT ISSUE. WHILE POSITIONING THE GUIDE WIRE UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THAT A PORTION OF THE RADIOPAQUE TIP WAS NOT VISIBLE. THE PHYSICIAN FELT THE DEVICE HAD FRACTURED AND OPTED TO REMOVE IT. THE WIRE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER IQ MARKER GUIDE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IQ MARKER GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7493895101J0 12704272

    Patients

    Seq Age Sex Outcome Treatment
    1