BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2150010 · Received July 5, 2011

    Report

    Report Number
    2024168-2011-04776
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 NC TREK CORONARY DILATATION CATHETER NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND IN THE HUB AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND USE OF THE PRODUCT IN THE PATIENT ANATOMY. THE BALLOON CATHETER WAS RETURNED TIGHTLY COILED IN A PLASTIC BAG AND IN THE CHIPBOARD BOX. THE BALLOON WAS SEPARATED AT THE PROXIMAL BALLOON SEAL. THE BALLOON INCLUDING THE TIP WAS NOT RETURNED. THE MATERIAL AT THE SEPARATION WAS JAGGED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE OUTER MEMBER WAS STRETCHED OVER THE PROXIMAL AND DISTAL BALLOON MARKERS, CAUSING THE PROXIMAL BALLOON SEAL TO BE LOCATED 2.5 MM DISTAL TO THE DISTAL BALLOON MARKER. THE INNER MEMBER WAS TWISTED 2 MM PROXIMAL TO THE PROXIMAL BALLOON MARKER, FOR A LENGTH OF 3 MM. THE SHAFT WAS STRETCHED AT TWO LOCATIONS. THE FIRST LOCATION WAS STRETCHED 1.5 MM DISTAL TO THE GUIDE WIRE EXIT NOTCH, FOR A LENGTH OF 1.7 CM. THE SECOND LOCATION WAS STRETCHED 6.2 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH, FOR A LENGTH OF 2 MM. THERE WERE MULTIPLE KINKS AND BENDS THROUGH OUT THE ENTIRE LENGTH OF THE HYPOTUBE. FACTORS THAT MAY CONTRIBUTE TO THE DIFFICULTY TO DEFLATE THE CATHETER INCLUDE, BUT ARE NOT LIMITED TO, UNEVENLY TRIMMED HYPOTUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED THUS BLOCKING THE FLOW OF CONTRAST, DEFLATION TECHNIQUE, CONTRAST CONCENTRATION, TORTUOUS ANATOMY, LOOSE CONNECTION WITH THE INDEFLATOR, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. IT IS POSSIBLE THAT THE HEAVILY CALCIFIED ANATOMY NARROWED THE INFLATION LUMEN, CONTRIBUTING TO THE REPORTED DIFFICULTY TO DEFLATE. ADDITIONALLY, DUE TO THE BALLOON UNABLE TO DEFLATE, THE INFLATED BALLOON LIKELY INTERACTED WITH THE SHEATH DURING ATTEMPTS TO REMOVE WHICH WOULD FURTHER RESULT IN THE SHAFT STRETCHING AND DAMAGE NOTED TO THE RETURNED CATHETER AS THERE WAS NO DAMAGE NOTED TO THE CATHETER DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. FURTHER, AS THE BALLOON WAS RUPTURED, IT IS POSSIBLE THAT THE BALLOON MATERIAL INTERACTED WITH THE ACCESSORY DEVICES OR ANATOMY, RESULTING IN THE BALLOON SEPARATING AND REMAINING IN THE PATIENT ANATOMY. IN THIS CASE, DUE TO THE CONDITION OF THE RETURNED PRODUCT, A CONCLUSIVE CAUSE FOR THE DEFLATION DIFFICULTIES COULD NOT BE CONFIRMED; HOWEVER THE DIFFICULTY REMOVING THE CATHETER AND SHAFT SEPARATION APPEAR TO BE RELATED TO THE BALLOON UNABLE TO DEFLATE. OCCLUSIONS ARE A KNOWN ADVERSE EVENT LISTED IN THE NC TREK INSTRUCTIONS FOR USE (IFU). IT IS LIKELY THAT AS THE BALLOON WAS UNABLE TO DEFLATE, THIS WOULD CAUSE AN OCCLUSION IN THE LESION. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORD FOR THIS LOT THAT WOULD BE RELATED TO THIS INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED FOR PROPER BALLOON FOLD CONFIGURATION AND DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION AND DEFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER DEPLOYING A STENT IN THE LEFT ANTERIOR DESCENDING ARTERY, A 4.5 X 13 MM ULTRA STENT WAS DEPLOYED AT 14 ATMOSPHERES (ATM) IN THE LEFT MAIN. BOTH VESSELS WERE EXTREMELY CALCIFIED. THE 5.0 X 12 MM NC TREK BALLOON WAS USED FOR POST-DILATATION OF THE ULTRA STENT. THE BALLOON WAS INFLATED TWICE (21 SECONDS AND 15 SECONDS) TO 16 ATM, BUT AFTER THE SECOND INFLATION, THE BALLOON WOULD NOT DEFLATE. TWO DIFFERENT SYRINGES WERE USED AND SEVERAL ATTEMPTS WERE MADE TO INFLATE AND DEFLATE THE BALLOON, BUT WERE UNSUCCESSFUL. THE CONTRAST MIXTURE WAS LESS THAN 1:1 AND ADDITIONAL SALINE WAS ADDED, BUT THIS DID NOT HELP. ALL THE DEVICES WERE THEN PULLED BACK TO THE AORTA AS A UNIT. SINCE THE NC TREK BALLOON COULD NOT BE PULLED INTO THE 6F SHEATH, THE BALLOON WAS INFLATED AND INTENTIONALLY RUPTURED. WHEN THE NC TREK CATHETER WAS REMOVED FROM THE PATIENT, THE BALLOON WAS OBSERVED TO BE MISSING. AFTER CONFIRMING THE BALLOON DID NOT REMAIN IN THE SHEATH, AN ANGIOGRAM AND AN ECHOCARDIOGRAM WAS PERFORMED, BUT THE SEPARATED BALLOON COULD NOT BE LOCATED IN THE PATIENT. DURING THE TIME THAT THE BALLOON REMAINED INFLATED IN THE LEFT MAIN, THERE WAS NO BLOOD FLOW THROUGH THE ARTERY; HOWEVER, THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AS HE HAD BEEN ON A BALLOON PUMP FROM THE BEGINNING OF THE PROCEDURE. THE PATIENT REMAINS HOSPITALIZED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1012661

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R STENT: 4.5X13 ULTRA, 3.0X15 VISION, SHEATH 6FR