BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 19373369 · Received May 22, 2024

    Report

    Report Number
    3005994106-2024-00008
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 22, 2024
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525786353
    PMA / PMN Number
    K211044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE PROXIMAL CATHETER SEGMENT WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED SHAFT SEPARATION AT THE RAPID EXCHANGE (RX) PORT. THERE WAS APPROXIMATELY 20MM OF ELONGATION OF THE CATHETER PAST THE SKIVE.

    Description of Event or Problem · 0

    THE BALLOON WAS BEING USED DURING A LEFT RADIAL TO PERIPHERY PROCEDURE. A GUIDE SHEATH WAS PLACED INTO THE RIGHT ILIAC ARTERY. AN 0.018" GUIDEWIRE WAS PLACED INTO THE DISTAL POPLITEAL ARTERY. A BALLOON CATHETER WAS PLACED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND INFLATED TO 12ATM WITH FULL APPOSITION. DURING BALLOON DEFLATION, BLOOD FLOW BACK INTO THE DEFLATOR WAS OBSERVED. WHEN RETRIEVING THE BALLOON, ONLY THE SHAFT WAS REMOVED FROM THE PATIENT'S BODY. THE BALLOON SEGMENT WAS STUCK INT EH DISTAL FSA. THE PATIENT WAS TRANSPORTED TO A HOSPITAL FOR SURGICAL REMOVAL. BALLOON DEFLATION CONFIRMATION WAS PERFORMED VIA ANGIOGRAM. NEGATIVE PRESSURE WAS HELD FOR APPROXIMATELY 2-3 SECONDS PRIOR TO REMOVAL. VERY LITTLE RESISTANCE WAS EXPERIENCED DURING REMOVAL. THERE WAS NO FURTHER PATIENT HARM. THE PATIENT HAD A FOLLOW-UP WITH THE PHYSICIAN IN TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570120 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC18-50100 22200870 05391525786353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention