BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2031865 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02063
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND BLOOD VISIBLE ON THE BALLOON, CRYSTALLIZED CONTRAST IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON, CONSISTENT WITH USE OF THE PRODUCT. THE NON-ABBOTT GUIDE WIRE USED DURING THE PROCEDURE WAS RETURNED. THE INNER DIAMETER OF THE GUIDE WIRE LUMEN WAS MEASURED AND IT MET MANUFACTURING CRITERIA. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS THE RETURNED GUIDE WIRE WAS BACK LOADED THROUGH THE GUIDE WIRE LUMEN WITHOUT RESISTANCE. ADDITIONALLY, THE CATHETER WAS PRESSURIZED TO THE RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES AND THERE WAS STILL NO RESISTANCE ADVANCING THE GUIDE WIRE. 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. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN A MODERATELY TORTUOUS CIRCUMFLEX ARTERY, THE PHYSICIAN FELT FRICTION BETWEEN THE RX TREK BALLOON AND A NON-ABBOTT GUIDE WIRE AS THE PHYSICIAN WAS PULLING THE TREK BALLOON OFF THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0111662

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BOSTON SCIENTIFIC FORTE