BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2142783 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04525
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE BMW GUIDE WIRE IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/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. 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 LOT NUMBER WAS NOT REPORTED. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TREK 2.0 X 12MM BALLOON DILATATION CATHETER WAS BEING USED OVER A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE TREATING A LESION IN THE CIRCUMFLEX ARTERY. THE LESION WAS NOT HIGHLY CALCIFIED AND THERE WAS NO TORTUOSITY. THE TREK BALLOON WAS INFLATED ONE TIME FOR 15 SECONDS AT 14 ATMOSPHERES. RESISTANCE WAS OBSERVED WITH THE GUIDE WIRE WHEN ATTEMPTING TO REMOVE THE TREK AFTER BALLOON DEFLATION. THE DECISION WAS MADE TO REMOVE BOTH DEVICES AS A UNIT TO AVOID MORE DAMAGE TO THE GUIDE WIRE. THE ENTIRE GUIDE WIRE WAS REMOVED FROM THE PATIENT; HOWEVER, A FRACTURE WAS OBSERVED BETWEEN THE SOFT AND THE RIGID PART. THE GUIDE WIRE WAS NOT SEPARATED IN TWO PIECES. THE NON-ABBOTT 5F GUIDING CATHETER WAS LEFT IN PLACE AND ANOTHER BMW WAS INSERTED TO COMPLETE THE STENTING PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR GUIDE WIRE: BMWGUIDE CATH: EBU 3.5 5F