BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2192155 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05512
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE CATHETER NOTED BLOOD VISIBLE ON THE BALLOON AND CRYSTALLIZED CONTRAST IN THE INFLATION LUMEN AND BALLOON, CONSISTENT WITH PREPARATION AND USE OF THE CATHETER IN THE PATIENT ANATOMY. THE BALLOON WAS FOLDED FLAT. THE OUTER MEMBER WAS NECKED 1 MM PROXIMAL TO THE PROXIMAL BALLOON SEAL FOR A LENGTH OF 1 MM. FACTORS THAT MAY CONTRIBUTE TO THE DIFFICULTY TO DEFLATE THE BALLOON 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. TO ENSURE THESE DIFFICULTIES ARE NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE 100% INSPECTED FOR PROPER BALLOON FOLD CONFIGURATION AND DAMAGE ONLINE, AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR PROPER BALLOON DEFLATION. THE OVERALL TOTAL LENGTH OF THE BALLOON CATHETER WAS MEASURED AND MET MANUFACTURING CRITERIA. THE BALLOON CATHETER WAS LEFT PRESSURIZED IN A WARM WATER BATH IN AN ATTEMPT TO DISSOLVE THE CRYSTALLIZED CONTRAST. AFTER THE CONTRAST DISSOLVED, A NEW INDEFLATOR FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER TO THE RATED BURST PRESSURE TO MEASURE THE DEFLATION TIMES. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS THE DEFLATION TIMES MET MANUFACTURING CRITERIA. IT WAS NOTED THAT AFTER THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT ANATOMY, THERE WAS A HIGH CONCENTRATION OF CONTRAST STILL IN THE BALLOON; THEREFORE, IT IS LIKELY THAT THE BALLOON WAS NOT COMPLETELY DEFLATED, WHICH WOULD CONTRIBUTE TO THE DIFFICULTY REMOVING THE CATHETER AND RESULTED IN A DELAY IN THE PROCEDURE; HOWEVER, A CONCLUSIVE CAUSE FOR THE DIFFICULTIES DEFLATING THE BALLOON COULD NOT BE DETERMINED. AS THERE WAS NO DAMAGE NOTED TO THE CATHETER DURING THE INSPECTION PRIOR TO USE AND THERE WAS NO REPORTED DIFFICULTY INFLATING THE BALLOON, IT IS LIKELY THAT THE NOTED SHAFT STRETCHING OCCURRED AS RESISTANCE WAS ENCOUNTERED DURING REMOVAL OR DURING HANDLING FOR RETURN TO ABBOTT VASCULAR. THE NOTED SHAFT STRETCHING DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT WAS NOTED DURING THE RETURNED DEVICE FUNCTIONAL TESTING THAT THE BALLOON DEFLATED FLAT, BUT A FLAT BALLOON IS NOT UNCOMMON (ESPECIALLY WHEN DEFLATED OUTSIDE OF THE BODY) AND IT IS UNKNOWN IF THE BALLOON DEFLATED IN THE SAME MANNER DURING USE. ADDITIONALLY, THE FULL LENGTH OF THE INNER MEMBER COLLAPSED DURING THE FUNCTIONAL TESTING DUE TO A GUIDE WIRE NOT PRESENT IN THE GUIDE WIRE LUMEN. IT WAS REPORTED THE CONTRAST SOLUTION WAS 50% CONTRAST DILUTED 1:1 WITH NORMAL SALINE. IT IS SPECIFIED IN THE TREK INSTRUCTIONS FOR USE, MATERIALS REQUIRED SECTION THAT THE CONTRAST IS 60% CONTRAST DILUTED 1:1 WITH NORMAL SALINE. AS THE DEFLATION TIMES WERE MEASURED AND MET MANUFACTURING CRITERIA, IT DOES NOT APPEAR THAT THE INCORRECT CONTRAST CONCENTRATION CONTRIBUTED TO THE REPORTED DIFFICULTIES. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL RECORDS FOR THE LOT RELATED TO THE INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED NO RELATED INCIDENTS; THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A 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 THE PROCEDURE IN THE MILDLY CALCIFIED DIAGONAL ARTERY, A 2.5 X 15 TREK DILATATION CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES SUCCESSFULLY. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON BUT THE BALLOON DID NOT DEFLATE. THE DILATATION CATHETER WAS WITHDRAWN FROM THE ANATOMY WITH SLIGHT RESISTANCE BUT WITHOUT INTERVENTION. OUTSIDE OF THE ANATOMY, IT WAS NOTED THAT THERE WAS A HIGH CONCENTRATION OF CONTRAST INSIDE THE BALLOON. A NEW NON-ABBOTT DILATATION CATHETER AND A NEW NC TREK DILATATION CATHETER WERE USED TO COMPLETE DILATATION. A NON-ABBOTT STENT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. REPORTED INFORMATION INDICATES THAT CONTRAST MEDIUM DILUTION WAS 50 PERCENT INSTEAD OF 60 PERCENT, AS INDICATED IN THE RX TREK INSTRUCTIONS FOR USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE PROCEDURE WAS PERFORMED IN THE PROXIMAL-MID, MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY FOR TREATEMT OF AN ECCENTRIC, DE NOVO, 85% STENOSED LESION. REPORTEDLY, THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WITHOUT ADVERSE PATIENT EFFECT. POST PROCEDURE STENOSIS WAS 0%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0100564

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR