BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2882479 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08219
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE RETURNED DEVICE ANALYSIS CONFIRMED THE REPORTED CONTAMINATION. A SEARCH OF THE COMPLAINT HANDLING DATABASE FOUND NO OTHER EVENTS REPORTED WITH CONTAMINATION FROM THIS PART/LOT COMBINATION. A REVIEW OF THE LOT HISTORY RECORD INDICATED NO RELATED NON-CONFORMANCE RECORDS FOR THIS SPECIFIC LOT. BASED ON THE RESULTS OF THE INVESTIGATION, THERE IS NO READILY IDENTIFIABLE EVIDENCE WHICH SUGGESTS A LARGER POPULATION OF TREK PRODUCT IS AFFECTED. THIS APPEARS TO BE A RARE OCCURRENCE AND WILL CONTINUE TO BE MONITORED PER SITE OPERATING PROCEDURES.

    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 ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE OPENING OF THE EXTERNAL PACKAGING, A FILAMENT SIMILAR TO A HAIR WAS OBSERVED ON THE COIL/HOOP CONTAINING THE 3.0X15 MM TREK BALLOON CATHETER. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS CONFIRMED THAT THE FILAMENT WAS A HUMAN HAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2011762

    Patients

    Seq Age Sex Outcome Treatment
    1