BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2230884 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06069
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED NC TREK BALLOON CATHETER FOUND CONTRAST VISIBLE ON THE SHAFT, CONSISTENT WITH HANDLING. THE BALLOON WAS RETURNED LOOSELY FOLDED. THE HYPOTUBE WAS SEPARATED 65.4 CM AND 77.5 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACES WERE OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THERE WAS AN ADDITIONAL BEND AND KINK NOTED TO THE HYPOTUBE. 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. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY TO POSITION THROUGH THE ROTATING HEMOSTATIC VALVE (RHV) INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE TO THE BALLOON, PRODUCT SIZE SELECTION, DAMAGE TO THE CATHETER OR ACCESSORY DEVICES, OR THE RHV NOT BEING FULLY OPEN AT THE TIME OF INSERTION. THE RHV USED DURING THE PROCEDURE WAS NOT RETURNED THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE 2/3 COLLAPSE BALLOON PROFILE WAS MEASURED AND MET MANUFACTURING CRITERIA. IT IS POSSIBLE THE RHV WAS NOT IN THE OPEN POSITION, CONTRIBUTING TO THE REPORTED RESISTANCE. FURTHER, AS RESISTANCE WAS ENCOUNTERED, THIS WOULD CONTRIBUTE TO THE HYPOTUBE KINKING. IT WAS REPORTED THE HYPOTUBE WAS ATTEMPTED TO BE STRAIGHTENED, WHICH LIKELY RESULTED IN THE SEPARATION. IT SHOULD BE NOTED THE CORONARY DILATATION CATHETER NC TREK RX INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE, OR ATTEMPT TO STRAIGHTEN, A CATHETER IF THE SHAFT HAS BECOME BENT OR KINKED; THIS MAY RESULT IN THE SHAFT BREAKING. INSTEAD, PREPARE A NEW CATHETER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY, THE 2.5 X 8 MM TREK BALLOON WAS PREPARED TO BE USED FOR POST-DILATATION. DURING INSERTION OF THE BALLOON CATHETER INTO THE Y-CONNECTOR, THE SHAFT KINKED. THE TREK WAS REMOVED, AND ATTEMPT WAS MADE TO STRAIGHTEN THE KINK; HOWEVER, DURING THE STRAIGHTENING ATTEMPT, THE SHAFT WAS BRITTLE, AND SEPARATED MID SHAFT, INTO THREE PIECES. ANOTHER DILATATION BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 1031761

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCESHEATH: RADIAL