BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PLUS PTCA GUIDEWIRE

    MDR report key: 1891133 · Received November 4, 2010

    Report

    Report Number
    2134265-2010-04753
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND TACTILE INSPECTION OF THE UNIT REVEALED LARGE AMOUNTS OF FOREIGN MATERIAL (FM) ALONG THE ENTIRE LENGTH OF THE WIRE WITH MORE CONCENTRATED AMOUNTS IN THE DISTAL PORTION. MICROSCOPIC INVESTIGATION OF THE WIRE CONFIRMED THAT THERE WERE DARK PURPLE FIBERS CLUMPED ALONG THE LENGTH IN WHAT APPEARED TO BE DRIED YELLOW CONTRAST MEDIA. FURTHER MICROSCOPIC EXAMINATION REVEALED SOME IRREGULARITIES JUST PROXIMAL TO THE HIGH TORQUE SLEEVE (HTS) - IT APPEARED THAT THERE WAS EITHER BUILD-UP OF CONTRAST MEDIA PRESENT ON THE DEVICE WHICH HAD DRIED AND CRACKED, OR THERE WAS A BUILD-UP OF HYDROPHILIC COATING. AFTER INITIAL ANALYSIS THE COMPLAINT DEVICE WAS DECONTAMINATED, ANALYSIS OF THE DECONTAMINATED WIRE REVEALED NONE OF THE ABOVE IRREGULARITIES - THE FM AND CONTRAST MEDIA WERE NOT PRESENT POST DECONTAMINATION WHICH WOULD SUPPORT THAT THE FM ENCOUNTERED THE DEVICE POST PROCEDURE. A SAMPLE FROM THE COMPLAINT DEVICE WAS GATHERED AND SENT FOR (B)(4) SPECTROSCOPY TO DETERMINE THE COMPOSITION OF THE POTENTIAL IRREGULAR COATING/CONTRAST VIEWED DURING MICROSCOPIC INVESTIGATION, THE RESULTS SUMMARIZED THE FOLLOWING: THE YELLOW MATERIAL APPEAR TO BE A BIOLOGICAL PROTEIN, SUCH A FIBRIN OR KERATIN. 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 DURING A STENTING TREATMENT PROCEDURE RESISTANCE WAS ENCOUNTERED AND THE COATING OF THE GUIDEWIRE WAS "COMING OFF". THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE LESION AND THEN A FLEXTOME CUTTING BALLOON WAS ADVANCED OVER THE WIRE AND INFLATED IN THE LESION. WHILE WITHDRAWING THE CUTTING BALLOON OVER THE WIRE THE PHYSICIAN EXPERIENCED A "TACKY" FEELING AND WITHDRAWAL RESISTANCE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, WHEN THE PHYSICIAN WAS WITHDRAWING THE SDS OVER THE WIRE HE EXPERIENCED A "TACKY" FEELING AND WITHDRAWAL RESISTANCE WITH THIS DEVICE AS WELL. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. IT WAS FURTHER NOTED THAT THE COATING OF THE GUIDEWIRE MAY HAVE PEELED OFF. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE RESISTANCE WAS ENCOUNTERED AND THE COATING OF THE GUIDEWIRE WAS "COMING OFF". THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE LESION AND THEN A FLEXTOME CUTTING BALLOON WAS ADVANCED OVER THE WIRE AND INFLATED IN THE LESION. WHILE WITHDRAWING THE CUTTING BALLOON OVER THE WIRE THE PHYSICIAN EXPERIENCED A "TACKY" FEELING AND WITHDRAWAL RESISTANCE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, WHEN THE PHYSICIAN WAS WITHDRAWING THE SDS OVER THE WIRE HE EXPERIENCED A "TACKY" FEELING AND WITHDRAWAL RESISTANCE WITH THIS DEVICE AS WELL. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. IT WAS FURTHER NOTED THAT THE COATING OF THE GUIDEWIRE MAY HAVE PEELED OFF. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PLUS PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122042 13520187

    Patients

    Seq Age Sex Outcome Treatment
    1 TAXUS LIBERTE STENT| FLEXTOME CUTTING BALLOON CATHETER