BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3160033 · Received June 10, 2013

    Report

    Report Number
    2024168-2013-03635
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT WAS RETURNED AND THE REPORTED INFLATION DIFFICULTY WAS CONFIRMED ON THE RETURNED DEVICE. THE REPORTED INFLATION DIFFICULTY WAS MOST LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED AND THE RETURN ANALYSIS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NC TREK WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THE NC TREK WAS ADVANCED TO THE LESION, BUT IT WOULD NOT INFLATE AT THE MODERATELY CALCIFIED TARGET LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY. ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO REPORTED ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WERE NO ISSUES NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259448 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30301G1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR