BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 4163578 · Received October 10, 2014

    Report

    Report Number
    2024168-2014-06589
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 15, 2014
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY WAS NOT CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE BALANCED MIDDLE WEIGHT (BMW) GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PLACEMENT OF THE BALANCED MIDDLE WEIGHT (BMW) GUIDE WIRE, THE 3.0X08MM TREK OTW BALLOON DILATATION CATHETER (BDC) WAS SUCCESSFULLY ADVANCED WITHOUT ISSUE. DURING AN ATTEMPT TO REMOVE THE BMW GUIDE WIRE FOR WIRE EXCHANGE, RESISTANCE WAS MET BETWEEN THE BMW GUIDE WIRE AND THE TREK BDC. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW BMW GUIDE WIRE AND A 2.5X08MM TREK OTW BDC WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639345 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40111G1

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCED MIDDLE WEIGHT (BMW)