BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2120277 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04105
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND CONTRAST VISIBLE IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION. THE ENTIRE LENGTH OF THE BALLOON WAS WRINKLED. THE INNER MEMBER INSIDE THE BALLOON WAS WRINKLED FROM THE DISTAL MARKER UP TO THE PROXIMAL MARKER. THERE WAS A TEAR IN THE DISTAL END OF THE TIP. THE DISTAL SHAFT WAS WRINKLED 1 CM PROXIMAL TO THE PROXIMAL SEAL FOR A LENGTH OF 5 MM. THE DISTAL SHAFT WAS ALSO WRINKLED 11.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 6 MM. THERE WAS A KINK IN THE DISTAL SHAFT 4.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS A BEND IN THE BAYONET PORTION OF THE HYPOTUBE 7.3 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THE BAYONET PORTION OF THE HYPOTUBE WAS TWISTED AND BENT 10.5 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT ARE NOT LIMITED TO: DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY. THE TIP LENGTH, TOTAL CATHETER LENGTH AND INNER DIAMETER OF THE GUIDE WIRE LUMEN WERE MEASURED AND MET MANUFACTURING CRITERIA. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. HOWEVER, A NEW .014 INCH GUIDE WIRE WAS BACK LOADED THROUGH THE BALLOON CATHETER WITH NO RESISTANCE NOTED. IT WAS REPORTED THE KISSING BALLOON TECHNIQUE WAS PERFORMED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE THE TREK CATHETER BECAME ENTANGLED WITH THE OTHER GUIDE WIRE USED, RESULTING IN RESISTANCE DURING ADVANCEMENT WHICH WOULD HAVE CONTRIBUTED TO THE DAMAGE NOTED TO THE CATHETER. FACTORS WHICH CAN CONTRIBUTE TO DEFLATION ISSUES INCLUDE, BUT ARE NOT LIMITED TO: LESION CHARACTERISTICS, PATIENT ANATOMICAL MORPHOLOGY, PRE-DILATATION STRATEGY, DEFLATION TECHNIQUE, INADEQUATE CONNECTION TO THE INDEFLATOR, OR CONTAMINATION IN THE INFLATION LUMEN. TO HELP ENSURE THAT THE REPORTED DEFLATION DIFFICULTIES ARE NOT RELATED TO A MANUFACTURING DEFICIENCY, ALL CATHETERS ARE 100% INSPECTED FOR DAMAGE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER INFLATION AND DEFLATION. AN INDEFLATOR, FILLED WITH CONTRAST DILUTED 1:1 WITH WATER, WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP) WITH NO DAMAGE NOTED TO THE BALLOON. AFTER NEGATIVE PRESSURE WAS APPLIED, THE BALLOON WOULD NOT DEFLATE. AFTER THE BALLOON CATHETER WAS PRESSURIZED OVERNIGHT TO DISSOLVE THE CONTRAST IN THE INFLATION LUMEN, THE BALLOON DEFLATED. THE INFLATION AND DEFLATION TIMES WERE MEASURED AND MET MANUFACTURING CRITERIA. IN THIS CASE, IT WAS REPORTED THE SHAFT OF THE CATHETER WAS DAMAGED DURING ADVANCEMENT OVER THE GUIDE WIRE, WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTIES DEFLATING THE BALLOON AS THE LUMEN OF THE CATHETER WAS KINKED AND BUNCHED. IT IS ALSO POSSIBLE THAT THE CONTRAST MIX RATIO MAY NOT HAVE BEEN PROPERLY DILUTED AND COULD HAVE CONTRIBUTED TO THE DEFLATION FAILURE. CONTRAST THAT IS MORE CONCENTRATED CAN LEAD TO SLOWER DEFLATION TIMES. IT IS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU) MATERIALS REQUIRED SECTION THAT THE CONTRAST IS 60% CONTRAST DILUTED 1:1 WITH NORMAL SALINE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DEFLATION ISSUES, BALLOON REFOLD, DIFFICULT TO POSITION, OR KINKS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK BALLOON CATHETER WAS ADVANCED TO THE LESION SITE DURING A MID LEFT ANTERIOR DESCENDING ARTERY PROCEDURE. THE TREK CATHETER CROSSED THE MODERATELY TORTUOUS AND CALCIFIED, CONCENTRIC, DE NOVO AND 75% STENOSED LESION SITE TO PERFORM THE KISSING BALLOON TECHNIQUE. HOWEVER, THE CATHETER WAS REDELIVERED DUE TO THE LESION SITE NOT BEING FULLY DILATED. DURING ADVANCEMENT, IT WAS ASSUMED THAT THE CATHETER GOT ENTANGLED WITH THE NON-ABBOTT GUIDEWIRE THAT WAS PREVIOUSLY PLACED. THE WHOLE SYSTEM WAS THEREFORE REMOVED TOGETHER. OBSERVATION OF THE TREK BALLOON REVEALED WRINKLES AND ALSO A BENT INNER MEMBRANE AND SO THE BALLOON WAS INFLATED OUTSIDE OF THE BODY IN AN ATTEMPT TO RE-WRAP THE BALLOON. ONCE INFLATED THE BALLOON WOULD NOT DEFLATE UNTIL THE SHAFT WAS STRAIGHTENED AND SO THE CATHETER WAS NOT USED FOR THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0092461

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR GUIDE WIRE: RINATO