BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2103538 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03719
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. INSTRUCTIONS FOR USE DEVIATION. 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 LOT HISTORY RECORD (LHR) FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE PART AND LOT NUMBERS WERE NOT REPORTED. WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. IT WAS REPORTED THE BALLOON OF THE TREK CATHETER WAS NOT SOAKED PRIOR TO USE. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IN THIS CASE, THE FAILURE TO SOAK THE BALLOON PRIOR TO USE DOES NOT APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES WITH THE GUIDE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GENERAL CONVERSATION WITH THE PHYSICIAN, HE MENTIONED THAT OVER THE PAST SEVERAL MONTHS HE HAS HAD THREE SEPARATE INCIDENTS WHERE AFTER BALLOON INFLATION OF THE RX MINI TREK, THE BALLOON WAS UNABLE TO BE REMOVED OVER THE BMW UNIVERSAL GUIDEWIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR PATIENT SEQUELA. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 BMW UNIVERSAL GUIDEWIRE