BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3822073 · Received May 20, 2014

    Report

    Report Number
    2024168-2014-03211
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: XT-R, GAIA 1, GAIA 2, RUNTHROUGH; GUIDE CATH: HEARTRAIL AL1 6F. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE TWO OTHER TREK BALLOON DILATATION CATHETERS (BDCS) REFERENCED ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A BRACHIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, 100% STENOSED, PROXIMAL CIRCUMFLEX ARTERY WITH A VESSEL DIAMETER OF 2.5 MM AND THE LESION LENGTH OF 10 MM, AFTER A GUIDE WIRE CROSSED THE LESION, A 1.2 X 6 MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERE (ATM). IT WAS REPORTED THAT THERE WAS RESISTANCE WITH THE LESION DURING ADVANCEMENT. THEN THE DEVICE WAS CHANGED TO A 2.0 X 15 MM NC TREK BDC AND RESISTANCE WAS MET WITH THE LESION DURING ADVANCEMENT AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATM. THEN THE DEVICE WAS CHANGED TO A 2.5 X 12 MM TREK RX BDC AND RESISTANCE WAS MET DURING ADVANCEMENT TO THE LESION. THEN THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATM. FINALLY THE PRE-DILATATION WAS PERFORMED WITH A 2.5 X 15 MM NC TREK BDC AND A 2.5 X 23 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE LESION. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300472 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21214G1

    Patients

    Seq Age Sex Outcome Treatment
    1