BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2062853 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02729
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. PATIENT AGE ESTIMATED AS HE WAS REPORTED TO BE IN HIS SIXTIES. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND GUIDE WIRE LUMEN, CONSISTENT WITH A LEAK WHILE IN THE PATIENT ANATOMY. THE BALLOON WAS LOOSELY FOLDED. THE INNER MEMBER WAS COLLAPSED FROM THE BALLOON MARKER FOR A LENGTH OF 20 CM. THE INNER MEMBER WAS TORN FOR A LENGTH OF 3 MM AND WRINKLED FOR A LENGTH OF 1 CM AT THE PROXIMAL END OF THE COLLAPSED INNER MEMBER. A NON-ABBOTT GUIDE WIRE WAS RETURNED INSIDE THE INNER MEMBER. THE GUIDE WIRE WAS SEPARATED AT THE PROXIMAL SOLDER. THE DISTAL PORTION (1.8 CM OF THE TIP COILS) WAS STUCK IN THE INNER MEMBER. THE SEPARATED COILS WERE MANGLED AND CAUGHT ON THE TEAR IN THE INNER MEMBER. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT 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. THE OUTER DIAMETER MEASUREMENTS OF THE NON-ABBOTT GUIDE WIRE AND THE INNER DIAMETER OF THE GUIDE WIRE LUMEN WERE NOT TAKEN DUE TO THE DAMAGE. ADDITIONALLY, ANY FUNCTIONAL TESTING COULD NOT BE DONE DUE TO THE DAMAGE NOTED AND THE DISTAL END OF THE GUIDE WIRE BEING STUCK INSIDE THE GUIDE WIRE LUMEN. IT WAS REPORTED THE OTW MINI TREK WAS USED SUCCESSFULLY WITH THE FIRST NON-ABBOTT GUIDE WIRE, WHICH SUGGESTS THERE WAS NO DAMAGE TO THE CATHETER PRIOR TO USE. IT IS POSSIBLE THAT THE SECOND GUIDE WIRE USED WAS DAMAGED; THEREFORE DURING ADVANCEMENT, THIS WOULD CONTRIBUTE TO THE NOTED DAMAGE TO THE INNER MEMBER. FURTHER, AN ATTEMPT TO MOVE THE GUIDE WIRE IN THIS CONDITION CAN CAUSE THE COILS TO BUNCH UP, INCREASING THE DIAMETER OF THE GUIDE WIRE, WHICH IN THE EXTREME CONDITION CAN CAUSE COIL OVERLAP. IF THE RESISTANCE IS NOT REDUCED AND CONTINUED FORCE IS APPLIED TO THE SYSTEM, THE RESULT IS PERMANENT DEFORMATION OF THE GUIDE WIRE AND/OR GUIDE WIRE LUMEN. INNER MEMBER COLLAPSE CAN BE A RESULT OF A MATERIAL DISCREPANCY, INCORRECT PREPARATION FOR USE, GUIDE WIRE SIZE SELECTION, OR HIGH PRESSURE/MULTIPLE INFLATIONS. HOWEVER, IN THIS CASE, IT IS UNKNOWN WHEN THE INNER MEMBER LUMEN MAY HAVE COLLAPSED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. DUE TO THE DAMAGE NOTED ON THE RETURNED PRODUCT, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND CHECKED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL POSTERIOR DESCENDING ARTERY, WITH MODERATE TORTUOSITY. THE TREK BALLOON WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE AND INFLATED WITHOUT ISSUE. THE CATHETER WAS THEN ADVANCED FURTHER DISTAL AND THE GUIDE WIRE WAS REMOVED TO EXCHANGE FOR A SOFTER TIP GUIDE WIRE. ANOTHER NON-ABBOTT GUIDE WIRE WAS THEN ADVANCED, BUT BECAME STUCK IN THE DISTAL END OF THE TREK CATHETER. AN ATTEMPT WAS MADE TO PULL THE CATHETER BACK, BUT IT WAS STUCK WITH THE GUIDE WIRE; THEREFORE, BOTH DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. ONCE OUTSIDE THE PATIENT, THE CATHETER WAS EXAMINED AND THERE WAS NO VISIBLE DAMAGE. A NEW TREK WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 0102061

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GUIDE WIRE: CHOICE PT2, CORDIS ATW