BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3912395 · Received July 3, 2014

    Report

    Report Number
    2024168-2014-04343
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 EVALUATION. THE REPORTED BALLOON DETACHMENT WAS CONFIRMED. BASED ON VISUAL 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 OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR BALLOON DETACHMENT REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PREPPING THE 3.0 X 25 MM NC TREK BALLOON, WHILE ATTEMPTING TO BACKLOAD THE DEVICE ONTO A GUIDE WIRE, IT WAS NOTED THAT THERE WAS NO BALLOON ATTACHED TO SHAFT. THE BALLOON WAS FOUND TO BE SEPARATED FROM THE SHAFT AND REMAINED INSIDE THE YELLOW PROTECTIVE SHEATH. IT COULD NOT BE CONFIRMED WHETHER OR NOT THERE WAS ANY RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER NON-COMPLIANT BALLOON WAS USED FOR THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391521 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40120G1

    Patients

    Seq Age Sex Outcome Treatment
    1