BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4123402 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06260
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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. THE DIFFICULT TO REMOVE THE PROTECTIVE SHEATH WAS NOT CONFIRMED DUE TO THE PROTECTIVE SHEATH NOT BEING RETURNED. THE REPORTED TWISTED MATERIAL WAS CONFIRMED TO BE NEAR THE PROXIMAL BALLOON SEAL AND NOT THE MIDDLE OF THE BALLOON. 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 SIMILAR INCIDENTS 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 BALLOON OF A 3.5 X 08 MM NC TREK BALLOON WAS TWISTED IN THE MIDDLE BEFORE USE. THERE WAS RESISTANCE REMOVING THE PROTECTIVE SHEATH. AN UNKNOWN BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. 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
    600308 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40510G1

    Patients

    Seq Age Sex Outcome Treatment
    1