BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 17813957 · Received September 25, 2023

    Report

    Report Number
    3005994106-2023-00007
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 29, 2023
    Report Date
    September 25, 2023
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525786339
    PMA / PMN Number
    K211044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE WAS RETURNED FOR ANALYSIS. DEVICE ANALYSIS CONFIRMED THE REPORTED ISSUE. THE DISTAL END OF THE BALLOON WAS DEFORMED IN A MANNER IN WHICH REMOVAL FROM THE ACCOMPANYING GUIDE SHEATH WAS NOT POSSIBLE. THE RETURNED BALLOON SEGMENT WAS UNABLE TO PASSED THROUGH THE RETURNED GUIDE SHEATH WITH ATTEMPTED.

    Description of Event or Problem · 0

    THE BALLOON WAS USED DURING AN ANGIOPLASTY PROCEDURE. THE GUIDE SHEATH WAS INSERTED INTO THE SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT ISSUE. DURING BALLOON REMOVAL, THE BALLOON GOT STUCK INSIDE THE GUIDE SHEATH AND WOULD NOT PULL THROUGH. THE PHYSICIAN TRIED TO PULL, BUT THE SHEATH WAS REMOVING AT THE SAME TIME AS THE BALLOON. THE PHYSICIAN THOUGHT THE BALLOON WAS UNSTUCK, BUT ONCE REMOVED, THE BALLOON SEGMENT WAS NOT ATTACHED TO THE HUB SEGMENT. THE BALLOON SEGMENT (WHICH CONTAINED THE RAPID EXCHANGE (RX) JUNCTION) WAS STUCK IN THE GUIDE SHEATH. THE SEPARATED SEGMENT WAS RETRIEVED WITH REMOVAL OF THE GUIDE SHEATH. IT WAS NOTED THE PHYSICIAN CONFIRMED BALLOON DEFLATION UNDER FLUOROSCOPY. THERE WAS NO IMPACT TO PATIENT OUTCOME OR PATIENT HARM. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833978 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC18-50060 22201819 05391525786339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown