BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3140996 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03444
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 6, 2013
    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). 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 AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE HI-TORQUE FLOPPY GUIDE WIRE AND 2.5X15 TREK REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING AN UNSPECIFIED ACCESS APPROACH FOR THE MODERATELY TORTUOUS, MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA), THE 2.5 X 15 MM TREK BALLOON DILATATION CATHETER (BDC) FELT SLUGGISH DURING ADVANCING BUT WAS POSITIONED OVER THE GUIDE WIRE AND INFLATED AT 12 ATMOSPHERE (ATM) WITHOUT ISSUE. DURING REMOVAL IT WAS STICKY BUT WAS SUCCESSFULLY REMOVED FROM THE ANATOMY WITHOUT THE GUIDE WIRE. THE HI-TORQUE FLOPPY GUIDE WIRE WAS POSITIONED AND THE 3.0 X 12 MM TREK BDC WAS ADVANCED AND INFLATED TO 12 ATM WITHOUT ISSUE. DURING REMOVAL THE BDC AND GUIDE WIRE BECAME STUCK AND WERE REMOVED TOGETHER AS A SYSTEM. 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
    244438 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR GUIDE WIRE: HI-TORQUE FLOPPY II