BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2183068 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05373
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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: BALANCE MIDDLEWEIGHT UNIVERSAL II. INFLATION: INDEFLATOR. GUIDE CATH: 6 FR JL4. 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: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION AND A LEAK WHILE IN THE PATIENT ANATOMY. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PULL NEGATIVE PRESSURIZE FROM THE BALLOON CATHETER. BUBBLES ENTERED THE SYRINGE. THE BALLOON CATHETER WAS THEN PRESSURIZED AND WATER LEAKED OUT OF THE TIP THEN THE GUIDE WIRE EXIT NOTCH. AFTER REMOVING THE OUTER MEMBER AND BALLOON FROM THE INNER MEMBER, IT WAS NOTED THAT THERE WAS A LONGITUDINAL LINE ON THE FULL LENGTH OF THE INNER MEMBER WHERE THE MATERIAL WAS THINNER. THERE WAS A TEAR ON THE LONGITUDINAL LINE 6.5 CM PROXIMAL TO THE PROXIMAL BALLOON MARKERS FOR A LENGTH OF 2 MM. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE INNER MEMBER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE GUIDE WIRE. TO HELP ENSURE THAT THIS DAMAGE IS NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR DAMAGE, INCLUDING AT THE POINT WHERE THE CATHETER IS INSERTED INTO THE PACKAGING COIL. ADDITIONALLY, ALL PRODUCTS ARE 100% LEAK TESTED PRIOR TO PACKAGING AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE CATHETER BODY INTEGRITY PRIOR TO RELEASE. IN THIS CASE, THERE WAS NO DAMAGE OR LEAK NOTED DURING THE INSPECTION PRIOR TO USE OR DURING PREPARATION WHICH SUGGESTS THE INNER MEMBER WAS NOT PREVIOUSLY DAMAGED. IT IS LIKELY THAT THE GUIDE WIRE INTERACTED WITH THE INNER MEMBER DURING BACK LOADING, RESULTING IN THE NOTED TEAR IN THE INNER MEMBER. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR LEAKS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE NOTED TEAR IN THE INNER MEMBER 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 LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WAS 85% STENOSED AND CALCIFIED. AFTER CROSSING THE LESION WITH A GUIDE WIRE, PREDILATATION WAS PLANNED WITH THE MINI TREK; HOWEVER, WHILE PREPARING THE BALLOON AND APPLYING NEGATIVE PRESSURE A LEAK WAS NOTED. IT WAS REPLACED WITH A NEW UNIT OF THE SAME SIZE. PRE-DILATATION WAS PERFORMED AND A XIENCE PRIME 2.5 X 18 MM WAS PLACED AT THE LESION SUCCESSFULLY. THE PROCEDURE FINAL RESULT WAS GOOD WITH TIMI FLOW 3. NO PATIENT EFFECTS WERE REPORTED. 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 1010564

    Patients

    Seq Age Sex Outcome Treatment
    1