BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 6191987 · Received December 20, 2016

    Report

    Report Number
    2024168-2016-09085
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    December 2, 2016
    Report Date
    January 9, 2017
    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). THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THERE WAS NO LEAK NOTED DURING PREPARATION PRIOR TO USE, WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IN THIS CASE IT IS LIKELY THAT THE BALLOON INTERACTED WITH THE MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 99% STENOSED LESION SUCH THAT THE BALLOON BECAME DAMAGED AND SUBSEQUENTLY RUPTURED DURING INFLATION. THE SAME ANATOMICAL CONDITIONS LIKELY CONTRIBUTED TO THE RESISTANCE MET DURING ADVANCEMENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE. GUIDE CATHETER: HYPERION AL. THE NC TRAVELER IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MODERATELY TORTUOUS, HEAVILY CALCIFIED, 99% STENOSED MID RIGHT CORONARY ARTERY. A 3.00 X 12 MM NC TRAVELER RX BALLOON DILATATION CATHETER (BDC) WAS SELECTED FOR PRE-DILATATION. THE BDC WAS ADVANCED AGAINST RESISTANCE TO THE LESION AND CROSSED. UPON THE FIRST INFLATION TO 15 ATMOSPHERES THE BALLOON RUPTURED AS EVIDENCED BY CONTRAST ESCAPING FROM BALLOON UNDER ANGIOGRAPHY. THE BDC WAS REMOVED FROM THE ANATOMY AND WHEN FLUSHED A LONGITUDINAL RUPTURE WAS NOTED AT MIDDLE OF BALLOON. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PRE-DILATATION AND THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL IMPLANTATION OF A XIENCE ALPINE STENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840347 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50824G1

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES