BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

    MDR report key: 1150006 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00726
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 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

    THE SECOND FLEXI-CUT (PART# 1003094-400/ LOT# 608252) IS INDICATED IN THE EVENT DESCRIPTION AND IS BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE FIRST ATHERECTOMY CATHETER WAS RETURNED WITH BLOOD VISIBLE ON THE SHAFT, BALLOON, CUTTER, AND IN THE INFLATION PORT, BALLOON, AND NOSECONE. THERE WAS CONTRAST VISIBLE IN THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE CUTTER WAS IN THE PROXIMAL END OF THE HOUSING. THERE WAS NO DAMAGE NOTED TO THE CATHETER. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED OUT OF A LONGITUDINAL RUPTURE 1 MM PROXIMAL TO THE DISTAL END OF THE BALLOON FOR A LENGTH OF 5.5 MM. THERE WAS A SCRATCH IN THE BALLOON PARALLEL TO THE LONGITUDINAL RUPTURE FOR A LENGTH OF 5 MM. THERE WAS ANOTHER LONGITUDINAL RUPTURE ON THE OPPOSITE SIDE FROM THE LONGITUDINAL RUPTURE ON THE TOP OF THE BALLOON. THERE WERE TWO HOLES IN THE MIDDLE OF THE BALLOON. THERE WAS A RADIAL SCRATCH ON THE DISTAL END OF THE BALLOON. THE SECOND FLEXI-CUT ATHERECTOMY CATHETER WAS RETURNED WITH BLOOD VISIBLE IN THE BALLOON, CUTTER, AND NOSECONE. THERE WAS CONTRAST VISIBLE IN THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE CUTTER WAS IN THE DISTAL END OF THE HOUSING. THERE WAS NO DAMAGE NOTED TO THE CATHETER. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED OUT OF A PINHOLE 5 MM DISTAL TO THE PROXIMAL END OF THE BALLOON. THERE WAS A SCRATCH DISTAL AND PROXIMAL TO THE PINHOLE. THERE WERE SCRATCHES VISIBLE ON THE HOUSING. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE CASE DESCRIPTION AND THE ANALYSIS OF THE DEVICES. BALLOON RUPTURES AND TEARS MAY OCCUR DUE TO, BUT ARE NOT LIMITED TO, MATERIALS, PATIENT ANATOMY, LESION MORPHOLOGY, PREPARATION TECHNIQUE, AND/OR DEVICE HANDLING. IT WAS REPORTED THAT THE TARGET LESION WAS 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE FIRST DEVICE WAS RETURNED WITH BLOOD VISIBLE ON THE SHAFT, BALLOON, CUTTER, AND IN THE INFLATION PORT, BALLOON, AND NOSECONE, CONSISTENT WITH USE INSIDE A PATIENT'S ANATOMY. ANALYSIS WAS ABLE TO CONFIRM THE REPORTED DIFFICULTY AS THE CATHETER WAS PRESSURIZED AND FLUID LEAKED OUT OF A LONGITUDINAL RUPTURE 1 MM PROXIMAL TO THE DISTAL END OF THE BALLOON FOR A LENGTH OF 5.5 MM. THERE WAS ANOTHER LONGITUDINAL RUPTURE OPPOSITE THE ABOVE RUPTURE ON THE TOP OF THE BALLOON AND TWO HOLES (TEARS) IN THE MIDDLE OF THE BALLOON. ANALYSIS ALSO REVEALED A RADIAL SCRATCH ON THE DISTAL END OF THE BALLOON SUGGESTING INTERACTION WITH ANOTHER OBJECT SUCH AS PATIENT ANATOMY OR AN ASSOCIATIVE DEVICE. ANALYSIS OF THE SECOND FLEXI-CUT WAS ABLE TO CONFIRM THE REPORTED DIFFICULTY AS THE CATHETER WAS PRESSURIZED AND FLUID LEAKED OUT OF A PINHOLE 5 MM DISTAL TO THE PROXIMAL END OF THE BALLOON. PRODUCT PERFORMANCE ENGINEERING FURTHER INVESTIGATED AND REVEALED SCRATCHES VISIBLE ON THE HOUSING. ADDITIONALLY, THE PINHOLE WAS LOCATED ALONG A SCRATCH FOR A LENGTH OF APPROXIMATELY 3 MM. THESE SCRATCHES SUGGEST INTERACTION WITH ANOTHER OBJECT SUCH AS PATIENT ANATOMY OR AN ASSOCIATIVE DEVICE. IT IS POSSIBLE THAT THIS INTERACTION CONTRIBUTED TO THE PINHOLE, LEADING TO THE REPORTED RUPTURE. OVERALL, SINCE THE DEVICES WERE ABLE TO BE PREPARED FOR USE, AND USED FOR SEVERAL CUTS, THE FAILURE APPEARS TO BE RELATED TO CIRCUMSTANCES DURING THE PROCEDURE. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMITIES ASSOCIATED WITH THIS LOT NUMBER. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED WITH THIS PART AND LOT COMBINATION. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENTS CIRCUMSTANCES. ALL CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY BALLOON RATED BURST PRESSURE (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 LESION WAS LOCATED IN THE LEFT MAIN TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WHICH HAD NO TORTUOSITY, NO CALCIFICATION, AND 90% STENOSIS. ANOTHER COMPANY'S GUIDE WIRE CROSSED THE LESION AND THEN THE GUIDE WIRE WAS REPLACED WITH THE FLEXI-WIRE USING A FINECROSS MICROCATHETER. THEN, DIRECTIONAL CORONARY ATHERECTOMY (DCA) WAS PERFORMED. CUTTING WAS PERFORMED USING THE FIRST FLEXI-CUT DEVICE; HOWEVER, THE BALLOON WAS NOTED TO BE RUPTURED WHEN CUTTING WAS DONE FOR THE SIXTH TIME AT 30 PSI. REPORTEDLY, THERE WAS NO CALCIFICATION IN THE LESION. THUS, A SECOND FLEXI-CUT WAS USED. THE BALLOON OF THE SECOND FLEXI-CUT ALSO RUPTURED WHILE PERFORMING DCA FOR THE TENTH TIME AT 20 PSI. 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 6080252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (PART#1003094-400/ LOT# 6080252)| ATHERECTOMY CATHETER: FLEXI-CUT 3.5 X 4.0| ADVANCE 3.0-15| STENT: TAXUS 3.0-16| DIL. CATH: MAVERICK 2.0-15| GUIDE WIRE: FLEXIWIRE| RINATO| RUNTHROUGH| GUIDE CATH: LAUNCHER JCL 4.0| OTHER: IVUS