BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2241556 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06242
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED BALLOON CATHETER FOUND BLOOD IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION AND USE OF THE CATHETER IN THE PATIENT ANATOMY. THE HYPOTUBE WAS SEPARATED 71 CM DISTAL TO THE STRAIN RELIEF TUBING AND THE DISTAL SHAFT WAS SEPARATED 13.5CM PROXIMAL TO THE DISTAL END OF THE TIP, CONFIRMING THE REPORTED SEPARATION. THE MIDDLE PORTION WAS NOT RETURNED. THE HYPOTUBE WAS OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THE DISTAL SHAFT WAS STRETCHED AND JAGGED AT THE SEPARATION WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THERE WERE MULTIPLE BENDS NOTED IN THE HYPOTUBE. FACTORS THAT CAN CONTRIBUTE TO SHAFT SEPARATIONS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING DURING PREPARATION, PRODUCT PLACEMENT TECHNIQUE, FRACTURE/KINKED SHAFT, OR WEAK SEALS. TO ENSURE THIS IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS, INCLUDING AT THE POINT THE PRODUCT IS PLACED IN THE COIL DISPENSER. THE BALLOON CATHETER WAS USED TWICE SUCCESSFULLY PRIOR TO THE ATTEMPT TO ADVANCE THE CATHETER A THIRD TIME WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IN THIS CASE, IT IS POSSIBLE THAT THE SHAFT WAS INADVERTENTLY HANDLED PRIOR TO ADVANCING THE CATHETER INTO THE GUIDING CATHETER, RESULTING IN THE DISTAL SHAFT SEPARATION; HOWEVER THIS COULD NOT BE CONFIRMED. ADDITIONAL HANDLING OF THE HYPOTUBE DURING PACKING FOR RETURN ANALYSIS LIKELY CONTRIBUTED TO THE HYPOTUBE SEPARATING AS THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE HYPOTUBE CAN LEAD TO WEAKENING OF THE HYPOTUBE MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. IT WAS REPORTED THE BALLOON WAS NOT SOAKED PRIOR TO USE. IT SHOULD BE NOTED THE NC TREK INSTRUCTIONS FOR USE (IFU) STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IT DOES NOT APPEAR THAT THE FAILURE TO SOAK THE BALLOON CONTRIBUTED TO THE SHAFT SEPARATIONS. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NONCONFORMANCES FOR THE LOT AND A SEARCH OF THE COMPLAINT DATABASE INDICATED NO RELATED INCIDENTS. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT PRESENTED WITH A NON-ST SEGMENT MYOCARDIAL INFARCTION. THE DISTAL CIRCUMFLEX WAS 90% STENOSED AND THE PROXIMAL CIRCUMFLEX WAS 65% STENOSED. THE DISTAL CIRCUMFLEX WAS TREATED FIRST USING THE NC TREK FOR PRE-DILATATION, FOLLOWED BY STENTING WITH A XIENCE V 2.5 X 23 MM. IT WAS REPORTED THAT THE NC TREK WAS MOST LIKELY NOT PREPPED ACCORDING THE INSTRUCTIONS FOR USE (NOT SOAKED). POST-DILATATION WAS THEN PERFORMED WITH THE NC TREK WITH NO ISSUE. THE NC TREK WAS THEN GOING TO BE USED FOR PRE-DILATATION OF THE PROXIMAL CIRCUMFLEX; HOWEVER, UPON ADVANCEMENT THROUGH THE GUIDING CATHETER, THE BALLOON CATHETER COULD NOT BE OBSERVED EXITING THE GUIDING CATHETER TOWARDS THE LESION SITE; NO RESISTANCE WAS FELT. APPARENTLY, THE DISTAL SHAFT SEPARATED AND REMAINED IN THE GUIDING CATHETER. THE NC TREK WAS REMOVED WITH THE GUIDING CATHETER FROM THE PATIENT'S ANATOMY AND NO INTERVENTION WAS REQUIRED. A NON-ABBOTT BALLOON CATHETER WAS USED FOR PRE-DILATATION OF THE PROXIMAL CIRCUMFLEX ARTERY AND A XIENCE V STENT(SIZE UNKNOWN) WAS IMPLANTED. THE PATIENT OUTCOME WAS FINE AND THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1040661

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR STENT: XIENCE V 2.5 X 23 MM