BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2132882 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04324
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD AND CONTRAST VISIBLE IN THE LOOSELY FOLDED BALLOON AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND A LEAK WHILE IN THE PATIENT ANATOMY. THE INNER MEMBER WAS COLLAPSED AND KINKED PROXIMAL TO THE PROXIMAL MARKER FOR A LENGTH 3 MM. THERE WERE MULTIPLE BENDS IN THE ENTIRE LENGTH OF THE HYPOTUBE. 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. 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. TO ENSURE THIS IS NOT THE RESULT OF 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. THE INNER DIAMETER OF THE GUIDE WIRE EXIT NOTCH AND THE INNER DIAMETER OF THE TIP UP TO THE COLLAPSED INNER MEMBER WERE MEASURED AND MET MANUFACTURING CRITERIA. 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. HOWEVER, THE REPORTED DIFFICULTIES WERE CONFIRMED AS NEW .014IN GUIDE WIRE COULD NOT BE BACK LOADED THROUGH THE BALLOON CATHETER DUE TO THE DAMAGE NOTED TO THE INNER MEMBER. INNER MEMBER COLLAPSE CAN BE A RESULT OF A MATERIAL DISCREPANCY, INCORRECT PREPARATION FOR USE, GUIDE WIRE SIZE SELECTION, OR HIGH PRESSURE/MULTIPLE INFLATIONS. AN INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON BUT THE BALLOON WOULD NOT PRESSURIZE. AFTER THE BALLOON CATHETER WAS LEFT PRESSURIZED OVERNIGHT TO DISSOLVE THE BLOOD AND CONTRAST IN THE IN THE BALLOON AND CONTRAST IN THE INFLATION LUMEN, THE BALLOON WAS PRESSURIZED BELOW THE RATED BURST PRESSURE (RBP) AND FLUID LEAKED FROM A PINHOLE RUPTURE IN THE MIDDLE OF THE BALLOON. THERE WERE NO SCRATCHES VISIBLE. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE LESION WAS REPORTED AS MODERATELY CALCIFIED AND MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. SCANNING ELECTRON MICROSCOPY (SEM) LAB ANALYSIS CONFIRMED TWO LEAKS IN THE BALLOON. IT WAS DETERMINED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. AS THERE WAS NO REPORT OF A LEAK OR DAMAGE NOTED TO THE BALLOON DURING PREPARATION FOR USE OR DURING THE PROCEDURE, IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, OR THE MODERATELY CALCIFIED LESION DURING RETRACTION OF THE PRODUCT AFTER INFLATIONS. INCIDENTALLY, AS THE BALLOON WAS UNABLE TO BE INFLATED, THE CATHETER WAS UNABLE TO BE CHECKED FOR REVERSIBLE INNER MEMBER COLLAPSE; THEREFORE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES REMOVING THE GUIDE WIRE COULD NOT BE DETERMINED. 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 OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES REMOVING THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER, THE NOTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION. THE 2.5 X 15 TREK BALLOON WAS INFLATED TWICE AT NOMINAL PRESSURE FOR 15 SECONDS EACH; HOWEVER, DURING REMOVAL, RESISTANCE WAS MET WITH A NON-ABBOTT GUIDE WIRE. ANOTHER 2.5 X 15 TREK BALLOON WAS USED TO COMPLETE 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 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1032361

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: FILTER FC WIRE