BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 22023505 · Received May 14, 2025

    Report

    Report Number
    3005994106-2025-00007
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 16, 2025
    Report Date
    May 14, 2025
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525785943
    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 WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE. THE BALLOON WAS RECEIVED IN TWO SEGMENTS. THE FRACTURE WAS JUST PROXIMAL TO THE RAPID EXCHANGE (RX) PORT. THERE WAS ALSO A KINK IN THE CATHETER NEAR THE STRAIN RELIEF.

    Description of Event or Problem · 0

    THE SITE REPORTED THE BALLOON CATHETER BROKE IN THE PATIENT'S BODY PRIOR TO INFLATION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. THE BALLOON CATHETER SHAFT BROKE PROXIMAL TO THE RAPID EXCHANGE (RX) PORT. THE ISSUE OCCURRED AFTER THE FIRST INFLATION. AFTER DEFLATION, THE CATHETER WAS ADVANCED FURTHER DISTALLY, THROUGH THE LESION AND CALCIFICATION. IT WAS NOTED RESISTANCE WAS FELT. IT WAS AT THIS TIME, THE SHAFT BROKE. THE COMPLETE BALLOON CATHETER WAS ABLE TO BE REMOVED. THE ISSUE HAPPENED AT THE CONCLUSION OF THE PROCEDURE. THE SUBLIME BALLOON WAS USED AFTER OTHER BALLOONS COULD NO CROSS THE LESION. THE PHYSICIAN WAS UNABLE TO RECROSS THE LESION WITH A GUIDEWIRE UPON BALLOON REMOVAL. THIS WAS WHERE THE PROCEDURE CONCLUDED. THERE WAS NO PATIENT HARM OR PROCEDURE DELAY DUE TO THE SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826608 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC18-20080 22300789 05391525785943

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male