BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2052197 · Received April 12, 2011

    Report

    Report Number
    2024168-2011-02572
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: BMW. GUIDE CATH: MDT AL2. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CATHETER WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE BALLOON WAS LOOSELY FOLDED, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR RUPTURE IN THE BALLOON. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER, BUT FLUID WAS UNABLE TO REACH THE BALLOON DUE TO THE DRIED BLOOD AND CONTRAST NOTED. THE DEVICE WAS LEFT PRESSURIZED OVERNIGHT AND THE ANALYSIS CONFIRMED THAT THERE WAS A PINHOLE IN THE BALLOON ABOVE THE DISTAL MARKER. THE RUPTURE WAS LOCATED AT A FOLD, UNDERNEATH A FLAP OF BALLOON MATERIAL. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONCLUDED THAT THE BALLOON FAILURE MAY POSSIBLY BE RELATED TO EXPOSURE CONDITIONS OR A MATERIAL/PROCESSING DISCREPANCY. THE LEAK WAS LOCATED UNDERNEATH A PEELED RADIAL FLAP OF BALLOON MATERIAL ABOVE THE DISTAL MARKER. THE PEELING APPEARED TO HAVE INITIATED IN A FOLD. THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE. HOWEVER, IT IS POSSIBLE THAT THE BALLOON WAS DAMAGED DURING MANUFACTURING, SUCH THAT IT CAUSED THE BALLOON TO PEEL AND RUPTURE UPON INFLATION ATTEMPT, THOUGH THIS CANNOT BE CONFIRMED. BALLOON MATERIAL RUPTURES MAY 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. REPORTEDLY, THE LESION WAS MODERATELY CALCIFIED AND MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FROM THIS LOT. A DEFINITIVE CAUSE FOR THE REPORTED RUPTURE COULD NOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KISSING BALLOON PROCEDURE, DURING INFLATION, A LEAKAGE WAS OBSERVED AT 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE DESPITE THE LEAKAGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 0072762

    Patients

    Seq Age Sex Outcome Treatment
    1