BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANGER PACLITAXEL-COATED PTA BALLOON CATHETER

    MDR report key: 18012512 · Received October 26, 2023

    Report

    Report Number
    2124215-2023-59696
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    UDI-DI
    08714729976042
    PMA / PMN Number
    P190019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RANGER AND GUIDEWIRE BECAME STUCK. A RANGER 5.0MM X 200MM, 150CM WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY (SFA) ATHERECTOMY PROCEDURE FOR ENDOVASCULAR THERAPY FOR PERIPHERAL ARTERY DISEASE. THE TARGET LESION HAD 90 PERCENT STENOSIS WITH MODERATE CALCIFICATION AND SEVERE TORTUOSITY. PRE-INFLATION WAS PERFORMED USING A 0.035 JUPITER AND MUSTANG 5MMX100MM TO APPLY THIS RANGER TO THE OPPOSITE DISTAL SFA; HOWEVER, THE RANGER WAS UNABLE TO CROSS THE LESION. THE GUIDEWIRE WAS REPLACED WITH CHEVALIER FLOPPY 0.014 GUIDEWIRE AND THIS RANGER BALLOON WAS TAKEN, BUT STILL NOT ADVANCING WELL DUE TO DIFFICULT ANATOMY OF THE ILIAC. THE PHYSICIAN PERSISTED AND TRIED TO ADVANCE, BUT THE RANGER GOT STUCK WITH THE GUIDEWIRE AND COULD NO LONGER BE USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567719 RANGER PACLITAXEL-COATED PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU BOSTON SCIENTIFIC CORPORATION 1973-03 03869H23 08714729976042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown