BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2232092 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06114
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    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. THE WHISPER GUIDE WIRE IS BEING FILED UNDER A SEPARATE MFR NUMBER. EVALUATION SUMMARY: EVALUATION OF THE RETURNED NC TREK DILATATION CATHETER NOTED BLOOD VISIBLE ON THE BALLOON AND CONTRAST IN THE LOOSELY FOLDED BALLOON CONSISTENT WITH PREPARATION AND THE CATHETER ADVANCED INTO THE PATIENT ANATOMY. THE BALLOON CATHETER WAS RETURNED ADVANCED THROUGH A NON-ABBOTT GUIDING CATHETER. THE DISTAL END OF THE BALLOON WAS WRINKLED AT THE DISTAL END OF THE GUIDING CATHETER, WHICH LIKELY OCCURRED DURING RETRACTION OF THE DEVICE. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 86 CM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES WITH THE GUIDE WIRE. THE GUIDE WIRE WAS RETURNED BACK LOADED THROUGH THE BALLOON CATHETER. THERE WAS 26.9 CM OF THE DISTAL END OF THE GUIDE WIRE EXTENDING FROM THE DISTAL END OF THE BALLOON CATHETER. THERE WAS BLOOD ON THE GUIDE WIRE POLYMER. 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 INNER DIAMETER OF THE GUIDE WIRE LUMEN AND THE OUTER DIAMETER OF THE GUIDE WIRE WERE MEASURED AND MET MANUFACTURING CRITERIA. THE BALLOON CATHETER COULD NOT BE REMOVED FROM THE GUIDING CATHETER AS THERE WAS RESISTANCE AT THE WRINKLED PORTION OF THE BALLOON. AFTER THE BALLOON WAS INFLATED AND THEN DEFLATED, THE BALLOON CATHETER WAS REMOVED FROM THE NON-ABBOTT GUIDING CATHETER. THE RETURNED GUIDE WIRE WAS ADVANCED THROUGH THE BALLOON CATHETER AND REMOVED WITH NO RESISTANCE NOTED. AFTER THE RETURNED GUIDE WIRE WAS BACK LOADED THROUGH THE BALLOON CATHETER, THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE (RBP) AND THE CATHETER WAS CHECKED FOR GUIDE WIRE REVERSIBILITY. THE GUIDE WIRE WAS NOT FROZEN IN THE GUIDE WIRE LUMEN WHILE THE BALLOON WAS PRESSURIZED. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS THE GUIDE WIRE WAS REMOVED WITH NO RESISTANCE NOTED AFTER THE INDEFLATOR WAS IN THE NEUTRAL POSITION. THE PATIENT ANATOMY WAS REPORTEDLY MILDLY TORTUOUS AND CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. ANATOMICAL CONDITIONS, SUCH AS TORTUOUS VESSELS, CAN CAUSE THE SHAPE OF THE GUIDE WIRE OR CATHETER TO BECOME ANGLED AND MAKE IT MORE DIFFICULT TO ADVANCE THE CATHETER OVER THE GUIDE WIRE. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE CATHETER. IN CERTAIN CIRCUMSTANCES, SUCH AS MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCES CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND COULD LEAD TO RESISTANCE. IT WAS REPORTED THE NC TREK BALLOON WAS INFLATED TO 22 ATMOSPHERES (ATM), WHICH IS ABOVE THE RBP. IT SHOULD BE NOTED THE NC TREK INSTRUCTIONS FOR USE STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RBP. IT DOES NOT APPEAR THAT THE OVER PRESSURIZATION OF THE BALLOON CONTRIBUTED TO THE RESISTANCE WITH THE GUIDE WIRE. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER INCIDENTS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    REPORTEDLY THE NC TREK BALLOON CATHETER WAS USED FOR POST DILATATION OF A VISION STENT (4.0X23) TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. AFTER USE OF THE NC TREK BALLOON CATHETER AT 22 ATM FOR POST DILATATION, THE BALLOON CATHETER BECAME STUCK ON AN UNKNOWN WHISPER GUIDE WIRE SO EVERYTHING WAS WITHDRAWN AS ONE UNIT. REPORTEDLY THE BALLOON WAS FULLY DEFLATED DURING ATTEMPTS TO WITHDRAW THE CATHETER AND THERE WAS NO RESISTANCE FELT BETWEEN THE VISION STENT AND THE BALLOON CATHETER. THE ONLY RESISTANCE FELT WAS WITH THE WHISPER GUIDE WIRE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE PATIENT EFFECTS. A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1013161

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR GUIDE WIRE: WHISPER