BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2082417 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03335
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 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). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE 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. THERE WAS A KINK IN THE HYPOTUBE 37 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WERE MULTIPLE BENDS IN THE FULL LENGTH OF THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A .0150 INCH FULL LENGTH MANDREL ADVANCED THROUGH THE FULL LENGTH OF THE GUIDE WIRE LUMEN, BUT THERE WAS RESISTANCE AT THE DISTAL END FOR A LENGTH OF 8 CM FROM THE BALLOON MARKER. 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. A NEW .014 INCH GUIDE WIRE WAS ADVANCED THROUGH THE GUIDE WIRE LUMEN. THERE WAS A LIGHT RESISTANCE NOTED AT NEUTRAL PRESSURE. AFTER THE BALLOON CATHETER WAS PRESSURIZED TO THE RATED BURST PRESSURE, IT WAS NOTED THAT THE GUIDE WIRE DID NOT MOVE FREELY IN THE GUIDE WIRE LUMEN. THE INNER MEMBER WAS COLLAPSED FOR A LENGTH OF 8 CM FROM THE BALLOON MARKER BAND. AT NEUTRAL PRESSURE THE GUIDE WIRE WAS REMOVED WITH LIGHT RESISTANCE. INNER MEMBER COLLAPSE CAN BE A RESULT OF A MATERIAL DISCREPANCY, INCORRECT PREPARATION FOR USE, GUIDE WIRE SIZE SELECTION, THE CATHETER PRESSURIZED WITHOUT THE GUIDE WIRE INSERTED, OR HIGH PRESSURE/MULTIPLE INFLATIONS. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE INNER MEMBER COLLAPSE COULD NOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS 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 PRODUCT DEFICIENCY, ALL PRODUCTS ARE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: SION, X-TREAM. GUIDE CATH: BRITE TIP 7F XB3.5, JR4.0. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE 1.5 X 6 MINI TREK WAS USED FOR DILATATION WITH EIGHT INFLATIONS AT 12 ATMOSPHERES (ATMS), FOR 8 SECONDS EACH, AND THREE INFLATIONS AT 14 ATMS, FOR 15 SECONDS EACH; HOWEVER, DURING THE 11TH INFLATION, DIFFICULTY WAS NOTED IN THE GUIDE WIRE ADVANCEMENT AND REMOVAL. A 1.2 X 6 MINI TREK WAS USED IN ADDITION TO OTHER NON-ABBOTT BALLOONS, TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 010096Q

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR