BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4111570 · Received September 23, 2014

    Report

    Report Number
    2024168-2014-06132
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED LEAK WAS CONFIRMED. THE REPORTED FAILURE TO INFLATE WAS NOT CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON VISUAL AND DIMENSIONAL 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 INCIDENTS FOR INFLATION DIFFICULTY OR LEAK REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. A 3.25 X 12 MM NC TREK WAS BEING USED FOR POST-DILATATION; HOWEVER, IT WOULD NOT INFLATE AND THERE APPEARED TO BE A LEAK IN THE DEVICE. THE DEVICE WAS REMOVED AND ANOTHER NC TREK BALLOON WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO RESISTANCE REMOVING THE PROTECTIVE SHEATH. THE CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591402 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30423G1

    Patients

    Seq Age Sex Outcome Treatment
    1