BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3830982 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03322
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT DETACHMENT WAS CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES OR EXCEPTIONS FOR THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF THE NC TREK BALLOON FROM THE PACKAGING, THE PROXIMAL SHAFT BECAME SEPARATED. NO RESISTANCE WAS NOTED DURING REMOVAL OF THE DEVICE FROM THE PACKAGING. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER NC TREK BALLOON OF THE SAME SIZE WAS USED ON THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307573 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40307G1

    Patients

    Seq Age Sex Outcome Treatment
    1