BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3223105 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04351
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED INFLATION DIFFICULTY WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED MID RIGHT ANTERIOR DESCENDING ARTERY. A 3.5 X 15 MM NC TREK WAS ADVANCED TO THE LESION AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE BALLOON COULD NOT INFLATE. ANOTHER 3.5 X 15 MM NC TREK WAS USED SUCCESSFULLY 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
    322917 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30205G1

    Patients

    Seq Age Sex Outcome Treatment
    1