BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAVELER RX CORONARY DILATATION CATHETER

    MDR report key: 6224120 · Received January 4, 2017

    Report

    Report Number
    2024168-2017-00092
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Date of Event
    December 15, 2016
    Report Date
    January 4, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648196652
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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 6F SPB3.5. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 SIMILAR 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. THE TRAVELER DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE PROCEDURE TO PRE-DILATE A CONCENTRIC, MODERATELY CALCIFIED, 75% STENOSED, DE NOVO LESION IN THE MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, A 2.25X12 TRAVELER RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND PREPPED WITH AIR ASPIRATION PERFORMED OUTSIDE OF PATIENT ANATOMY. THE BDC WAS THEN ADVANCED AND CROSSED THE LESION WITHOUT RESISTANCE. DURING THE 2ND INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES AFTER 20 SECONDS. THE TRAVELER RX BDC WAS WITHDRAWN WITHOUT RESISTANCE. A NON-ABBOTT BDC WAS USED TO PERFORM PRE-DILATATION WITHOUT ISSUE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED VIA PLACEMENT OF A 2.5X18 XIENCE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6360 TRAVELER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50914G1 08717648196652

    Patients

    Seq Age Sex Outcome Treatment
    1