BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX?

    MDR report key: 4192172 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06382
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A KINETIX GUIDEWIRE AND AN EXTRA KINETIX GUIDEWIRE. THE EXTRA GUIDEWIRE WAS NOT DAMAGED. THE GUIDEWIRE WAS COMPLETELY SEPARATED 37.7CM FROM THE TIP. MAGNIFIED INSPECTION OF THE FRACTURE SURFACES APPEAR TO BE CONSISTENT WITH SEPARATION DUE TO DUCTILE BENDING OVERLOAD. THERE WAS NO DAMAGE OR IRREGULARITIES TO THE BONDS. 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 GUIDEWIRE DETACHMENT/SEPARATION OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING(LAD) ARTERY. A 185CM KINETIX¿ GUIDEWIRE WAS ADVANCED TO THE TARGET LESION. THEN, A NON-BSC BALLOON CATHETER WAS ADVANCED THROUGH THE GUIDEWIRE TO DILATE THE TARGET LESION. HOWEVER, UPON REMOVAL OF THE BALLOON, THE GUIDEWIRE CAME OUT ALL TOGETHER AND THE PHYSICIAN NOTED THAT THE GUIDEWIRE HAS DETACHED. THE DETACHED GUIDEWIRE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GUIDEWIRE DETACHMENT/SEPARATION OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING(LAD) ARTERY. A 185CM KINETIX¿ GUIDEWIRE WAS ADVANCED TO THE TARGET LESION. THEN, A NON-BSC BALLOON CATHETER WAS ADVANCED THROUGH THE GUIDEWIRE TO DILATE THE TARGET LESION. HOWEVER, UPON REMOVAL OF THE BALLOON, THE GUIDEWIRE CAME OUT ALL TOGETHER AND THE PHYSICIAN NOTED THAT THE GUIDEWIRE HAS DETACHED. THE DETACHED GUIDEWIRE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673395 KINETIX? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122010 17065158

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR GENOSIS 2.5X15 BALLOON CATHETER