BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2060318 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02681
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 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. GUIDE WIRE: FIELDER FC. GUIDE CATH: LAUNCHER. OTHER: CORSAIR (MICROCATHETER FOR CTO). THE 2.5X12MM TREK IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE SHAFT, HYPOTUBE AND CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS FLAT. THIS IS CONSISTENT WITH PREPARATION, THE CATHETER ADVANCED INTO THE PATIENT ANATOMY AND MULTIPLE INFLATIONS PERFORMED. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT 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 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. THE INNER DIAMETER OF THE GUIDE WIRE LUMEN WAS MEASURED AND MET MANUFACTURING CRITERIA. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED; THEREFORE, IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. A NEW .014 INCH GUIDE WIRE WAS BACK LOADED THROUGH THE RETURNED BALLOON CATHETER AND ADVANCED THROUGH WITHOUT RESISTANCE NOTED. THE NEW GUIDE WIRE WAS THEN INSERTED IN THE GUIDE WIRE LUMEN OF THE RETURNED BALLOON CATHETER AND A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE TO CHECK GUIDE WIRE MOVEMENT FOR COLLAPSED LUMEN. WHILE PRESSURIZED THE GUIDE WIRE WAS NOT ABLE TO MOVE AND STRONG RESISTANCE WAS FELT. THE GUIDE WIRE LUMEN WAS COLLAPSED 5.2 CM PROXIMAL TO THE PROXIMAL BALLOON SEAL, FOR A LENGTH OF 1.2 CM. NEGATIVE PRESSURE WAS PULLED AND THE GUIDE WIRE WAS REMOVED FROM THE RETURNED BALLOON CATHETER WITHOUT RESISTANCE NOTED. INNER MEMBER COLLAPSE CAN BE A RESULT OF A MATERIAL DISCREPANCY, INCORRECT PREPARATION FOR USE, GUIDE WIRE SIZE SELECTION, OR HIGH PRESSURE/MULTIPLE INFLATIONS, AND AS THE GUIDE WIRE LUMEN WAS NOTED TO BE NOT COLLAPSED AFTER PRESSURIZATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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 HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO REMOVE THE GUIDE WIRE OR INNER MEMBER COLLAPSE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS THE MID RIGHT CORONARY ARTERY AND WAS A CHRONIC TOTAL OCCLUSION. A 1.2X8MM MINI TREK BALLOON PERFORMED THE FIRST PRE-DILATATION SUCCESSFULLY. THEN A 2.0X12MM MINI TREK WAS DELIVERED AND ADDITIONAL DILATATION WAS PERFORMED THREE TIMES AT 12 ATMOSPHERES (ATM). UPON REMOVAL, RESISTANCE WAS NOTED WITH A NON-ABBOTT GUIDE WIRE WHEN THE BALLOON WAS WITHDRAWN INSIDE GUIDING CATHETER. THE CATHETER WAS RE-POSITIONED AND A FOURTH DILATATION WAS PERFORMED. AFTER THIS, THE CATHETER WAS STUCK WITH THE GUIDE WIRE DURING THE WITHDRAWAL RESULTING IN BOTH DEVICES BEING REMOVED AS A SINGLE UNIT. A 2.5X15MM TREK WAS DELIVERED ON THE SAME GUIDE WIRE, AND DILATATION WAS PERFORMED TWICE AT 8 AND 10ATM. IT WAS WITHDRAWN FROM THE PATIENT WITHOUT RESISTANCE. TO PERFORM THE THIRD DILATATION, WHEN AN ATTEMPT WAS MADE TO ADVANCE THE CATHETER ONTO THE GUIDE WIRE, RESISTANCE WAS NOTED BETWEEN THE DISTAL PART OF THE INNER MEMBER AND THE PROXIMAL END OF THE WIRE OUTSIDE THE PATIENT ANATOMY. IT WAS REPLACED WITH A 2.5 X 12 TREK, WHICH WAS DELIVERED ON THE SAME GUIDE WIRE AND DILATATION WAS PERFORMED ONCE AT 12ATM. IT WAS WITHDRAWN FROM THE PATIENT WITHOUT RESISTANCE. THE CATHETER WAS RE-DELIVERED AND PERFORMED THE SECOND DILATATION AT 12ATM. DURING THE WITHDRAWAL, THE CATHETER WAS STUCK WITH THE GUIDE WIRE AGAIN AND WITHDRAWN FROM THE PATIENT AS A SINGLE UNIT. IT WAS REPLACED WITH A NON-ABBOTT CATHETER, OVER THE SAME GUIDE WIRE AND TWO XIENCE V STENTS WERE DEPLOYED TO COMPLETE 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 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0091661

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR