BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAVELER RX CORONARY DILATATION CATHETER

    MDR report key: 5212853 · Received November 9, 2015

    Report

    Report Number
    2024168-2015-06676
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 22, 2015
    Report Date
    November 9, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE 2.5X12MM TRAVELER REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE TRAVELER RX 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 PERFORMED TO TREAT A 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. THE 2.0 X 12 MM TRAVELER BALLOON CATHETER WAS ADVANCED WITH SOME RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED TO 6 ATMOSPHERES (ATM), FOR 10 SECONDS, BUT RUPTURED ON THE FIRST INFLATION. THE DEVICE WAS REMOVED WITH RESISTANCE, AND REPLACED. THE 2.5 X 12 MM TRAVELER BALLOON CATHETER WAS ADVANCED WITH RESISTANCE WAS NOTED AGAIN WITH THE ANATOMY. THE BALLOON WAS INFLATED TO 6 ATM, FOR 10 SECONDS, BUT RUPTURED ON THE FIRST INFLATION. THE DEVICE WAS REMOVED WITH RESISTANCE, AND REPLACED. AN NC TREK BALLOON CATHETER WAS USED TO CONTINUE THE PROCEDURE 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
    742884 TRAVELER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40623G1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR