BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4182798 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06802
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SEPARATION WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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/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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY PROCEDURE, THERE WAS RESISTANCE DURING ADVANCEMENT OF THE 3.0 X 8 MM NC TREK BALLOON DILATATION CATHETER AND IT FAILED TO CROSS THE TARGET LESION DUE TO INTERACTION WITH A PREVIOUSLY IMPLANTED STENT. DURING REMOVAL OF THE BALLOON DILATATION DEVICE, THE HYPOTUBE BROKE. ANOTHER DEVICE WAS USED FOR POST-DILATATION OF THE STENT AND TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661607 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40521G1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR