BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 2011557 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00766
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION DETAILS ARE UNKNOWN. THE KINETIX GUIDE WIRE WAS PLACED IN THE PATIENT. AN ATLANTIS SR PRO² CORONARY IMAGING CATHETER WAS ADVANCED OVER THE WIRE. AT AN UNSPECIFIED TIME, THE IMAGE WAS LOST. WHILE ATTEMPTING TO REMOVE THE ATLANTIS CATHETER, IT WAS NOTED THAT IT HAD BECOME STUCK ON THE KINETIX GUIDE WIRE. DURING REMOVAL ATTEMPTS THE WIRE BECAME KINKED. THE DEVICES WERE REMOVED TOGETHER AS A UNIT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDE WIRE AND ANOTHER ATLANTIS CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122010 13530362

    Patients

    Seq Age Sex Outcome Treatment
    1 ATLANTIS SR PRO² CORONARY IMAGING CATHETER