BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2832312 · Received November 14, 2012

    Report

    Report Number
    2024168-2012-07185
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 THIS WAS AN UN-SPECIFIED CORONARY PROCEDURE. THE 3.0 X 15 MM TREK BALLOON WAS PREPARED PER THE INSTRUCTIONS FOR USE, PRIOR TO USE IN THE ANATOMY. THE BALLOON WAS ADVANCED WITHOUT ISSUE FOR PRE-DILATATION AND INFLATED TO AN UNKNOWN PRESSURE. IT WAS OBSERVED THAT NO CONTRAST WAS SEEN IN THE BALLOON, AND THE BALLOON DID NOT INFLATE. THE BALLOON WAS REMOVED WITHOUT ISSUE AND ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON OUTSIDE THE ANATOMY, BUT THE BALLOON STILL WOULD NOT INFLATE. A NEW TREK BALLOON WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2053062

    Patients

    Seq Age Sex Outcome Treatment
    1