BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2090414 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03512
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS 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. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE PART AND LOT NUMBERS WERE NOT REPORTED. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TREK BALLOON WAS INFLATED; HOWEVER, DURING REMOVAL, RESISTANCE WAS NOTED BETWEEN THE BALLOON AND THE GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS 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

    Patients

    Seq Age Sex Outcome Treatment
    1