BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2060171 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02650
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 OTW TREK DILATATION CATHETER, AND THE MINI VISION STENT SYSTEM ARE BEING FILED UNDER SEPARATE MEDWATCH MFR REPORTS. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT ARE 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 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. RETURN OF THE OTW TREK CATHETER AND GUIDE WIRE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0101861

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR GUIDE WIRE: HI-TORQUE WHISPER