BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 1831998 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03980
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    VISUAL AND TACTILE INSPECTION OF THE DEVICE REVEALED A SEPARATION WHERE THE CORE WIRE IS INSERTED AND WELDED INTO THE INCONEL TUBE, IT APPEARS THAT THE CORE WIRE HAS PULLED OUT OF THE TUBE. FURTHER MICROSCOPIC INVESTIGATION REVEALED 4 SPOT WELDS ON THE INCONEL TUBE, BUT NO EVIDENCE OF PENETRATION ON THE COREWIRE WAS VISIBLE WITH THE LIGHT MICROSCOPE. THE UNIT WAS SUBMITTED TO THE ANALYTICAL LABORATORY FOR FURTHER ANALYSIS AND THE FOLLOWING CONCLUSIONS WERE DRAWN: THE NITINOL CORE WIRE SEPARATED FROM THE INCONEL TUBE DUE TO POOR WELD PENETRATION IN THE NITINOL WIRE. ONLY ONE OF THE FOUR WELDS SHOWED EVIDENCE OF A BOND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING AS THERE IS EVIDENCE THAT NOT ALL FOUR WELDS WERE PRESENT ON THE RETURNED DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    QUESTION: PLEASE INDICATE IF THE RETURNED PRODUCT FINDINGS OF INADEQUATE WELDING RESULT IN A CORRECTIVE OR PREVENTIVE ACTION. RESPONSE: YES, CORRECTIVE AND PREVENTIVE ACTIONS WERE IMPLEMENTED TO ADDRESS THE LOWER WELD TENSILE STRENGTH DUE TO INCOMPLETE INSERTIONS OF THE CORE WIRE INTO THE INCONEL COUPLER. VISUAL AIDS WERE UPDATED TO ENHANCE COMPONENT CLARITY, COUPLER LOADING DIFFICULTY INSTRUCTIONS WERE UPDATED IN THE LASER COUPLER WELDING WORK INSTRUCTIONS AND PROTOCOLS AND REPORTS WERE UPDATED TO INCLUDE THE REPORTED DEFECTS AND THE RESULTS OF THE TEST METHOD VALIDATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY INTERVENTION PROCEDURE A GUIDEWIRE SEPARATION OCCURRED. WHEN THE PACKAGE FOR THE KINETIX GUIDEWIRE WAS OPENED IT WAS NOTED THAT IT LOOKED AS IF THE WIRE HAD BEEN 'SEVERED OR SPLIT APART'. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY INTERVENTION PROCEDURE A GUIDEWIRE SEPARATION OCCURRED. WHEN THE PACKAGE FOR THE KINETIX GUIDEWIRE WAS OPENED IT WAS NOTED THAT IT LOOKED AS IF THE WIRE HAD BEEN "SEVERED OR SPLIT APART". THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY INTERVENTION PROCEDURE A GUIDEWIRE SEPARATION OCCURRED. WHEN THE PACKAGE FOR THE KINETIX GUIDEWIRE WAS OPENED IT WAS NOTED THAT IT LOOKED AS IF THE WIRE HAD BEEN "SEVERED OR SPLIT APART". THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H7493912202J2 13368144

    Patients

    Seq Age Sex Outcome Treatment
    1