BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2870912 · Received December 12, 2012

    Report

    Report Number
    2024168-2012-07880
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED SEPARATION WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE NC TREK RX DILATATION CATHETER WAS BEING BACKLOADED ON THE GUIDEWIRE AND ADVANCED INTO THE GUIDING CATHETER, THE MIDDLE OF THE SHAFT SEPARATED. THE POINT OF SEPARATION WAS OUTSIDE THE ANATOMY AND THE DISTAL SHAFT WAS EASILY REMOVED FROM THE PATIENT. THE INTENDED TARGET LESION WAS IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ANOTHER NC TREK RX WAS USED TO COMPLETE THE POST DILATATION WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1072261

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR