BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2212340 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05755
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE TIGHTLY FOLDED BALLOON AND ON THE SHAFT, CONSISTENT WITH THE CATHETER ADVANCED INTO THE PATIENT ANATOMY. THE NON-ABBOTT GUIDE WIRE WAS RETURNED FROZEN IN THE BALLOON CATHETER. THERE WAS A KINK IN THE SUPPORT WIRE 3 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK 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. THERE WAS 106 CM OF THE DISTAL END OF THE GUIDE WIRE EXTENDING OUT OF THE DISTAL END OF THE BALLOON CATHETER. THERE WERE BENDS IN THE GUIDE WIRE TIP AND A KINK IN THE GUIDE WIRE CORE 1 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH OF THE BALLOON CATHETER. AN ATTEMPT WAS MADE TO REMOVE THE NON-ABBOTT GUIDE WIRE FROM THE BALLOON CATHETER, BUT THE GUIDE WIRE WAS NOT ABLE TO BE REMOVED. AFTER THE GUIDE WIRE AND BALLOON CATHETER WERE SOAKED IN THE WATER BATH, THE GUIDE WIRE STILL WAS NOT ABLE TO BE REMOVED. IN THIS CASE, IT IS POSSIBLE THAT THE BUILD UP OF BLOOD AND CONTRAST ON THE GUIDE WIRE AND IN THE GUIDE WIRE LUMEN OF THE CATHETER CONTRIBUTED TO THE REPORTED DIFFICULTIES; HOWEVER, THIS COULD NOT BE CONFIRMED. 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 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. 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 OTHER INCIDENTS REPORTED FOR DIFFICULTY REMOVING THE GUIDE WIRE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. DUE TO THE CONDITION OF THE RETURNED PRODUCT, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES WITH THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, A NON-ABBOTT GUIDE WIRE WAS ADVANCED SUCCESSFULLY. AN ATTEMPT WAS MADE TO ADVANCE A 3.50 X 8 NC TREK DILATATION CATHETER BUT RESISTANCE WAS FELT. EACH TIME THAT THE CATHETER WAS ADVANCED, THE GUIDE WIRE WOULD MOVE WITH IT. THE CATHETER WAS REMOVED FROM THE GUIDE WIRE WITH RESISTANCE. A NON-ABBOTT DILATATION CATHETER WAS ADVANCED OVER THE SAME GUIDE WITHOUT RESISTANCE AND POST-DILATATION OF A PREVIOUSLY IMPLANTED NON-ABBOTT STENT WAS PERFORMED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL 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 1021061

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: CHOICE PT