BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3023579 · Received March 27, 2013

    Report

    Report Number
    2024168-2013-01754
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED KINK IN THE SHAFT WAS CONFIRMED. ALTHOUGH THERE WAS A KINK REPORTED IN THE BALLOON, A SEPARATION WAS CONFIRMED AT THAT LOCATION. 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 WHEN OPENING THE PACKAGING AND REMOVING THE NC TREK BALLOON CATHETER FROM THE HOOP, THE PHYSICIAN OBSERVED THAT THE CATHETER WAS DAMAGED. TWO KINKS WERE NOTED AT THE HYPOTUBE AND THE BALLOON WAS KINKED AT THE PROXIMAL PART. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER UNIT WAS USED WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. RETURNED DEVICE ANALYSIS NOTED THAT THE INNER MEMBER OF THE CATHETER WAS SEPARATED AT THE PROXIMAL END OF THE PROXIMAL BALLOON MARKER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127233 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21027G1

    Patients

    Seq Age Sex Outcome Treatment
    1