BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3243255 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04613
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: SION BLUE, RUNTHROUGH; GUIDE CATH: HEARTRAIL BL 3.5 7F. 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 BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. 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 90% STENOSED LESION IN THE PROXIMAL TO DISTAL CIRCUMFLEX ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. THE 2.25 X 12 MM NC TREK BALLOON CATHETER WAS ADVANCED WITHOUT ISSUE. THE BALLOON WAS INFLATED TO 14 ATMOSPHERES (ATM) FOR 30 SECONDS. DURING THE SECOND INFLATION OF 15 ATM, FOR 20 SECONDS, THE BALLOON RUPTURED AND THE DEVICE WAS REMOVED WITHOUT RESISTANCE. IT WAS NOTED THAT THE NC TREK WAS PREPARED PER THE INSTRUCTIONS FOR USE, PRIOR TO USE IN THE ANATOMY. A NEW BALLOON CATHETER WAS USED SUCCESSFULLY. 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
    343319 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2091261

    Patients

    Seq Age Sex Outcome Treatment
    1