BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2223725 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05944
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE CATHETER NOTED BLOOD AND CONTRAST VISIBLE IN THE LOOSELY FOLDED BALLOON AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND A RUPTURE WHILE IN THE PATIENT ANATOMY. AN INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON BUT THE BALLOON WOULD NOT PRESSURIZE. AFTER THE CATHETER WAS LEFT PRESSURIZED TO DISSOLVE THE BLOOD AND CONTRAST, THE BALLOON WAS PRESSURIZED AND FLUID WAS OBSERVED LEAKING FROM A 1 MM LONGITUDINAL RUPTURE IN THE BALLOON 0.5 MM PROXIMAL TO THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. THERE WERE NO VISIBLE SCRATCHES. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. SCANNING ELECTRON MICROSCOPY ANALYSIS NOTED THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LONGITUDINAL LEAK WAS LOCATED ON A FOLD CREASE AND EXHIBITED MATERIAL PUSHED INWARD. MECHANICAL DAMAGE WAS FOUND AT THE EDGES OF THE LEAK. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. THE PATIENT ANATOMICAL CONDITIONS WERE NOT REPORTED WITH THE CASE INFORMATION WHICH MAY HAVE AIDED IN THE INVESTIGATION. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH THE LESION/ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON INFLATION AT AN UNKNOWN PRESSURE; HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE. IT WAS REPORTED THE BALLOON WAS NOT SOAKED PRIOR TO USE WHICH ALSO MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE. IT SHOULD BE NOTED THE MINI TREK INSTRUCTIONS FOR USE STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IT DOES NOT APPEAR THAT THE FAILURE TO SOAK THE BALLOON PRIOR TO USE CONTRIBUTED TO THE REPORTED RUPTURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.0 X 12 MINI TREK RX BALLOON DILATATION CATHETER WAS ADVANCED INTO THE PATIENT ANATOMY. DURING INFLATION, THE BALLOON WOULD NOT INFLATE AND A HOLE WAS NOTED IN THE BALLOON. THE DILATATION CATHETER WAS REMOVED FROM THE PATIENT ANATOMY AND A NEW SAME SIZE MINI TREK RX WAS USED FOR DILATATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND 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 1042961

    Patients

    Seq Age Sex Outcome Treatment
    1