BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3203551 · Received July 3, 2013

    Report

    Report Number
    2024168-2013-04160
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. EVENT, IMPLANT, AND THERAPY DATES: ESTIMATED DATE (REPORTED AS OCCURRING TWO WEEKS PRIOR TO ALERT DATE ON (B)(6) 2013).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BALLOON DILATATION CATHETER (BDC) WAS RETURNED WITH NO DAMAGE NOTED. A QUERY REVEALED NO OTHER INCIDENTS FOR LEAKS OR AIR IN THE SYSTEM REPORTED FROM THIS BDC LOT. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO NONCONFORMING MATERIAL RECORDS (NCMRS) THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THERE WAS NO POTENTIAL PRODUCT DEFICIENCY IDENTIFIED WITH THE BDC. DURING INITIAL FUNCTIONAL TESTING, THE BALLOON HELD PRESSURE AND THERE WAS AIR AT THE DISTAL END OF THE BALLOON. ADDITIONAL TESTING WAS PERFORMED AND THE BALLOON HELD PRESSURE AND THERE WAS NO AIR AT THE DISTAL END OF THE BALLOON. A STOPCOCK WAS RETURNED ATTACHED TO THE HUB OF THE BALLOON CATHETER. A LEAK TEST WAS PERFORMED WITH A TEST INDEFLATOR AND THE RETURNED STOPCOCK AND BECAUSE BUBBLES WERE NOTED WHEN NEGATIVE WAS PULLED, THIS SUGGESTS THAT THE LIKELY CAUSE FOR THE REPORTED AIR NOTED IN THE DISTAL END OF THE BALLOON WAS DUE TO THE STOPCOCK PULLING IN AIR DURING PREPARATION. WITH AIR INTRODUCED INTO THE SYSTEM, ONCE PRESSURE IS APPLIED TO INFLATE THE BALLOON, THE AIR WOULD LIKELY BEEN SEEN IN THE DISTAL END OF THE BALLOON AS REPORTED. A LEAK IN THE STOPCOCK WAS CONFIRMED. IN THIS CASE, A POTENTIAL PRODUCT DEFICIENCY HAS BEEN IDENTIFIED WITH THE STOPCOCK. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES IS BEING PERFORMED AND APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NC TREK BALLOON DILATATION CATHETER WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE MANUAL AND ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 14 ATMOSPHERES WITH AN INDEFLATOR 30/30 INFLATION DEVICE AND THERE WAS AIR NOTED IN THE DISTAL END OF EACH OF THE BALLOONS. THE DEVICE WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED. WITH THE DEVICE RETURN THERE WAS AN UNKNOWN STOPCOCK THAT WAS FOUND TO BE LEAKING DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304793 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20605G1

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION: INDEFLATOR 30/30