BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 22057109 · Received May 20, 2025

    Report

    Report Number
    3005994106-2025-00008
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 20, 2025
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525786353
    PMA / PMN Number
    K211044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE BALLOON CATHETER WAS RETURNED FOR ANALYSIS. ANALYSIS COULD NOT CONFIRM THE ALLEGATION OF BALLOON BURST. THE BALLOON WAS RETURNED IN TWO SEGMENTS. THE BALLOON SEPARATED JUST PROXIMAL TO THE RAPID EXCHANGE (RX) PORT. THE BALLOON SEGMENT COULD NOT BE FULLY DEFLATED OR INFLATED TO CONFIRM A BALLOON BURST DUE TO NOT BEING INTACT. DUE TO THE RETURNED CONDITION, A BALLOON BURST COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE BALLOON CATHETER WAS USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE BALLOON BURST OCCURRED DURING THE FIRST INFLATION, APPROXIMATELY HALFWAY THROUGH THE INTENDED INFLATION PERIOD (1-2 MINUTES). THE BURST OCCURRED AT A PRESSURE OF 16ATM. TWO DIFFERENT BALLOON SIZES WERE USED AT OTHER VESSEL SEGMENTS AT A PRESSURE OF 10ATM WITHOUT ANY ISSUE. THE PHYSICIAN CHOSE TO USE THIS SPECIFIC BALLOON AFTER CONFIRMING THE PRESSURE RANGE OF 8ATM (NOMINAL PRESSURE) TO 16ATM (RATED BURST PRESSURE). THE USE OF THIS BALLOON WAS THE FINAL INTENDED PASS FOR THE PROCEDURE. AFTER THE BALLOON BURST OCCURRED, THE PHYSICIAN CONFIRMED THE COMPLETE BALLOON WAS FULLY IN THE PROCEDURAL SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER AND INSPECTED ON THE BACK TABLE. THE PHYSICIAN THEN PROCEEDED TO SITE CLOSURE. THE PHYSICIAN PLANNED TO BRING THE PATIENT BACK AT ANOTHER TIME FOR A BELOW THE KNEE PROCEDURE. THE TARGET VESSEL HAD SEVERE STENOSIS AND TORTUOSITY. THERE WAS NO SIGNIFICANT PROCEDURE DELAY DUE TO THE BALLOON BURST. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81436 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC18-50100 22201313 05391525786353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown