BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 23430555 · Received October 30, 2025

    Report

    Report Number
    3005994106-2025-00015
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 30, 2025
    Manufacturer
    CREAGH MEDICAL LTD.
    Product Code
    LIT
    UDI-DI
    05391525786148
    PMA / PMN Number
    K211044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE BALLOON CATHETER WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE. THE BALLOON CATHETER WAS RETURNED IN TWO SEGMENTS ON THE GUIDEWIRE AND THROUGH A GUIDE SHEATH. THE BALLOON SEPARATED NEAR THE RAPID EXCHANGE (RX) PORT. THE BALLOON SEGMENT WAS STILL ON THE GUIDEWIRE. THE PROXIMAL SEGMENT OF THE BALLOON WAS OFF THE GUIDEWIRE AND OUT OF THE GUIDE SHEATH. THE DISTAL SEGMENT OF THE BALLOON WAS TRAPPED ON THE GUIDEWIRE BY A SEVERE KINK.

    Description of Event or Problem · 0

    THE SUBLIME BALLOON CATHETER WAS USED DURING A LOWER EXTREMITY INTERVENTION VIA RIGHT RADIAL ACCESS TO TREAT AN OCCLUDED ANTERIOR TIBIAL ARTERY. THE PHYSICIAN REPORTED THAT MULTIPLE MANIPULATIONS OF THE DEVICE WERE REQUIRED TO ATTEMPT TO CROSS THE LESION. THE GUIDEWIRE WAS BELIEVED TO HAVE KINKED PROXIMAL TO THE LESION, WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA). UPON WITHDRAWAL OF THE BALLOON CATHETER, RESISTANCE WAS ENCOUNTERED AT THE LOCATION OF THE WIRE KINK. THE PHYSICIAN APPLIED GENTLE TRACTION, AT WHICH POINT THE BALLOON COMPONENT SEPARATED FROM THE CATHETER SHAFT AND REMAINED INSIDE THE VASCULATURE WHILE STILL ATTACHED TO THE GUIDEWIRE. A SECONDARY BALLOON CATHETER (JADE BALLOON) WAS SUBSEQUENTLY ADVANCED AND USED TO TRAP AND RETRIEVE THE SEPARATED BALLOON SEGMENT, ENABLING SUCCESSFUL REMOVAL OF THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS PROLONGED DUE TO THE RETRIEVAL PROCESS (OVER AN HOUR), AND PEDAL ACCESS WAS REQUIRED TO COMPLETE TREATMENT OF THE TARGET VESSEL. THERE WAS NO REPORTED PATIENT HARM OR ADVERSE CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342147 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL LTD. SRA-DC18-30220 22401635 05391525786148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown