BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4221190 · Received November 3, 2014

    Report

    Report Number
    2024168-2014-07170
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE TO INFLATE WAS CONFIRMED. THE REPORTED FAILURE TO DEFLATE WAS NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL 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 INFLATION OR DEFLATION ISSUES 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 THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH MILD CALCIFICATION. THE 3.5 X 12 MM NC TREK BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND ADVANCED TO THE LESION. WHEN AN ATTEMPT WAS MADE TO INFLATE THE BALLOON TO 10 ATMOSPHERES (ATM), THE BALLOON DID NOT EXPAND. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE NC TREK WAS REMOVED. OUTSIDE THE ANATOMY, THE BALLOON WAS ABLE TO BE INFLATED WITH THE SAME INDEFLATOR, BUT WOULD NOT DEFLATE. A NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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
    703354 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40130GA

    Patients

    Seq Age Sex Outcome Treatment
    1