BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX?

    MDR report key: 4745632 · Received May 4, 2015

    Report

    Report Number
    2134265-2015-02607
    Event Type
    Injury
    Date Received
    May 4, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 7, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 MDR ID: 2134265-2015-02877. IT WAS REPORTED VIA FACILITY MEDWATCH 0000390 145-2015-0001 THAT TIP DETACHMENT OCCURRED. AFTER AN UNKNOWN PROMUS STENT WAS IMPLANTED AT THE RIGHT CORONARY ARTERY, SIDE BRANCH STENOSIS OCCURRED AT THE RIGHT VENTRICULAR BRANCH (RV) AND THE PATIENT STARTED TO DEVELOP CHEST PAIN AND ST ELEVATION. THE PHYSICIAN THEN ADVANCED A 185CM KINETIX¿ GUIDE WIRE THROUGH THE STENT. AT THAT TIME, THE PATIENT WAS FEELING BETTER, THE ST SEGMENT DEPRESSED, SO THE PHYSICIAN RETRACTED THE KINETIX WIRE BACK INTO THE GUIDE CATHETER. ANGIOGRAPHY WAS PERFORMED AND NOTICED THAT THERE WAS A FRACTURED TIP IN THE LEFT RV BRANCH AND SOME OF IT IN THE RIGHT MAIN CORONARY ARTERY. IVUS WAS PERFORMED IN THE RIGHT CORONARY ARTERY AND REVEALED A FRACTURED TIP STICKING A LITTLE BIT IN THE SIDE BRANCH INTO THE MAIN RIGHT CORONARY ARTERY. THE PHYSICIAN ENDED UP USING A SNARE TO RETRIEVE THE FRACTURED TIP HOWEVER, FAILED. A 3.0 APEX BALLOON CATHETER WAS THEN SELECTED TO PIN THE FRACTURED TIP AGAINST THE WALL OF THE VESSEL AND BE ABLE TO DRAG BACK INTO THE GUIDE CATHETER, BUT WAS UNSUCCESSFUL. A SECOND PROMUS STENT WAS IMPLANTED TO PIN THE FRACTURED TIP IN PLACE AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290635 KINETIX? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122012 17727021

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention