BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

    MDR report key: 1060748 · Received June 11, 2008

    Report

    Report Number
    2024168-2008-00478
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MCX
    PMA / PMN Number
    P890043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE REVEALED THAT THE ATHERECTOMY CATHETER WAS RETURNED WITH BLOOD AND CRYSTALLIZED CONTRAST VISIBLE ON THE CUTTER AND IN THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THERE WAS NO DAMAGE NOTED TO THE CATHETER. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER, BUT DUE TO THE DRIED CONTRAST, THE BALLOON WOULD NOT INFLATE. THE CATHETER WAS LEFT PRESSURIZED FOR THREE DAYS; YET, DUE TO THE DRIED CONTRAST THE BALLOON WOULD STILL NOT INFLATE. PRODUCT PERFORMANCE ENGINEERING HAS REVIEWED CASE DESCRIPTION AND ANALYSIS OF THE RETURNED DEVICE, DAMAGE WAS NOTED. FACTORS THAT MAY CONTRIBUTE TO THE REPORTED DIFFICULTIES INCLUDE, BUT NOT LIMITED TO, MANUFACTURING, MATERIALS, PATIENT ANATOMY, PATIENT DISEASE STATE, ASSOCIATIVE DEVICE INTERACTION, LESION TORTUOSITY, OVER INFLATION, OR INSUFFICIENT PREPARATION PRIOR TO USE. THE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED DIFFICULTIES, AS ATTEMPTS TO REPLICATE THE CASE DESCRIPTION WERE UNSUCCESSFUL. THE PATIENT ANATOMY WAS MILDLY CALCIFIED AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE INSTRUCTIONS FOR USE STATES "...FILL BALLOON USING THE INFLATION DEVICE TO 60 PSI (4 ATM) MAX PRESSURE." IT WARNS THAT " THE FLEXI-CUT CATHETER SHOULD BE USED ONLY WITH A GUIDANT LOW PRESSURE INFLATION DEVICE OR OTHER MANUFACTURER'S INFLATION DEVICE WITH PRESSURE MONITORING CAPABILITY. FAILURE TO DO SO MAY RESULT IN BALLOON RUPTURE DUE TO OVERPRESSURIZATION AND IF SO, WILL CONSEQUENTLY INJURE THE VESSEL." THE CASE DESCRIPTION STATES THE ATHERECTOMY DEVICE WAS PRESSURIZED TO 14 ATM, WHICH EXCEEDS THE RATED BURST PRESSURE (RBP). OVERPRESSURIZATION OF THE DEVICE MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. BASED ON THE RETURNED DEVICE AND CASE DESCRIPTION, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES DURING THE PROCEDURE. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NONCONFORMANCES ASSOCIATED WITH THIS PRODUCT PART/LOT NUMBER COMBINATION. PRODUCT PERFORMANCE ENGINEERING AND/OR THE RESPECTIVE BUSINESS UNIT, QUALITY ENGINEERING GROUP, WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL CATHETERS ARE 100% VISUALLY INSPECTED FOR BALLOON DAMAGE AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY BALLOON RBP INTEGRITY. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE TARGET LESION WAS THE PROXIMAL LAD WITH MILD TORTUOSITY, MILD CALCIFICATION AND WITH 90% STENOSIS. SINCE THE VESSEL DIAMETER WAS BIG AND ANGLED CX BIFURCATION, THE RUPTURE WAS NOTED WHEN THE FLEXI-CUT WAS INFLATED AT 14 ATM DURING THE SECOND INFLATION. THE PROCEDURE WAS COMPLETED USING A NEW FLEXI-CUT AND IMPLANTING ANOTHER COMPANY'S STENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM 74MCX MCX ABBOTT VASCULAR-CARDIAC THERAPIES NA 6080352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDING CATHETER: MACH 1 FCL 3.5 SH| DILITATION CATHETER: QUANTUM MAVERICK| GUIDE WIRE: GLAND SLAM| FORTIS| OTHER ELECTRICAL: EAGLE EYE GOLD| STENT: 3.5 X 20 MM TAXUS