BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3170846 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03739
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND THE REPORTED INFLATION DIFFICULTY WAS NOT CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 3.0X15 TREK REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY FOR TREATMENT OF A 80% STENOSIS, A NON-ABBOTT GUIDE WIRE WAS DELIVERED AND PRE-DILATATION WAS PERFORMED USING A 3.0X15 TREK BALLOON AT 14 ATMOSPHERES (ATMS). DUE TO THE HEAVY CALCIFICATION, THE BALLOON COULD NOT FULLY EXPAND; THEREFORE, THE DEVICE WAS WITHDRAWN AND PRE-DILATATION WAS PERFORMED AT 18 ATMS USING A 3.0X15 NC TREK RX DILATATION CATHETER. THE BALLOON COULD NOT FULLY EXPAND DUE TO THE HEAVY CALCIFICATION. THE DEVICE WAS WITHDRAWN FROM THE ANATOMY AND THE PATIENT WAS REFERRED FOR CORONARY ARTERY BYPASS SURGERY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271535 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2032762

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR GUIDE WIRE: RUNTHROUGH