BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAVELER RX CORONARY DILATATION CATHETER

    MDR report key: 7940761 · Received October 5, 2018

    Report

    Report Number
    2024168-2018-07726
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 14, 2018
    Report Date
    October 5, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 CATH: HYPERION 6FR SPB3.5. THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. 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 REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. 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 THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MILDLY TORTUOUS AND HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. A 2.5 X 15 MM TRAVELER BALLOON DILATATION CATHETER (BDC) WAS USED AND WAS INFLATED TWICE AT 10 ATMOSPHERES. IT WAS REPORTED THAT THE DEVICE MAY HAVE MET INITIAL RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON THEN RUPTURED DURING THE SECOND INFLATION; THEREFORE, THE DEVICE WAS REPLACED WITH A NON-ABBOTT BDC TO SUCCESSFULLY 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
    781567 TRAVELER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80129G1

    Patients

    Seq Age Sex Outcome Treatment
    1