BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3162332 · Received June 11, 2013

    Report

    Report Number
    2024168-2013-03638
    Event Type
    Malfunction
    Date Received
    June 11, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOR ANALYSIS AND THE REPORTED DIFFICULTY REMOVING THE PROTECTIVE SHEATH WAS CONFIRMED. THE SHEATH WAS WRINKLED; HOWEVER, THERE WAS NO OTHER DAMAGE NOTED ON THE BALLOON CATHETER. BASED ON AN EXPANDED INVESTIGATION AND FURTHER REVIEW OF THE COMPLAINT HANDLING DATABASE AND OTHER SOURCES OF NONCONFORMITY DATA, IT WAS DETERMINED THAT THE DEVICES PERFORMANCE WITH REGARDS TO THE DIFFICULTY WITH REMOVING THE PROTECTIVE SHEATH WAS POTENTIALLY RELATED TO A MANUFACTURING ISSUE. CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE ARE IN THE PROCESS OF BEING IMPLEMENTED AND THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UN-PACKAGING OF THE 3.5 X 15 MM NC TREK BALLOON CATHETER, THE PROTECTIVE SHEATH COULD NOT BE REMOVED FROM THE BALLOON. THE NURSE PULLED THE SHEATH HARD AND THE SHAFT BECAME STRETCHED AND THE BALLOON WAS TORN. THE DEVICE WAS NOT USED. A NEW NC TREK BALLOON CATHETER WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED. ANALYSIS FOUND THAT THE SHAFT WAS NOT STRETCHED AND THE BALLOON WAS NOT TORN. THE ACCOUNT CONFIRMED THAT THE CORRECT DEVICE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262379 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30206G1

    Patients

    Seq Age Sex Outcome Treatment
    1