BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3667704 · Received March 7, 2014

    Report

    Report Number
    2024168-2014-01326
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 10, 2014
    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: RUNTHROUGH HC; GUIDE CATHETER: LAUNCHER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED BALLOON LEAK WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. BASED ON THE VISUAL/SCANNING ELECTRON MICROSCOPY 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 THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS 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 MILDLY TORTUOUS, MILDLY CALCIFIED, AND 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.25 X 15 MM NC TREK BALLOON CATHETER WAS USED FOR PRE-DILATATION. A NON-ABBOTT STENT WAS IMPLANTED. THE SAME NC TREK WAS RE-FOLDED USING THE PROTECTIVE SHEATH; HOWEVER, WHEN AIR ASPIRATION WAS PERFORMED TO USE THE DEVICE FOR POST-DILATATION, THERE WAS AN AIR LEAK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139309 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30708G1

    Patients

    Seq Age Sex Outcome Treatment
    1