BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MDS 0415222 KONIG ANDREWS-PYNCHON SUCTION TUBE

    MDR report key: 23085037 · Received September 18, 2025

    Report

    Report Number
    MW5176246
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    September 10, 2025
    Report Date
    September 15, 2025
    Manufacturer
    UNKNOWN
    Product Code
    KCB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SUCTION TIP CAME OFF ANDREWS SUCTION AND BECAME LODGED WITHIN BLOOD VESSEL. AGGRESSIVE ATTEMPTS MADE TO REMOVE THE SUCTION TIP WITH NO SUCCESS. SURGEON MADE DECISION TO KEEP TIP WITHIN PATIENT TO LATER BE REMOVED VIA IR APPROACH. PROCEDURES 1. RIGHT LOWER EXTREMITY ANGIOGRAM. 2. RIGHT POPLITEAL ARTERY ANGIOPLASTY, 6 MM BALLOON. 3. RIGHT PROXIMAL SFA SELF-EXPANDING STENT, 6 X 80. 4. RIGHT SFA ENDARTERECTOMY WITH BOVINE PERICARDIAL PATCH ANGIOPLASTY. 5. REPAIR OF RIGHT PROFUNDA FEMORIS VEIN. 6. ASCENDING VENOGRAM OF THE RIGHT LOWER EXTREMITY AND ILIAC VEIN. 7. ANGIOPLASTY OF THE RIGHT ILIAC VEIN. 8. ATTEMPTED SNARE AND FORCEPS GRASP OF EMBOLIZED FOREIGN BODY. 9. RETROPERITONEAL EXPOSURE OF THE RIGHT ILIAC VEIN. 10. REPAIR OF THE RIGHT ILIAC VEIN AND DEEP PELVIC VEINS. 11. RIGHT ILIAC VEIN 20 X 9.5 GORE EXCLUDER ILIAC LIMB PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287193 MDS 0415222 KONIG ANDREWS-PYNCHON SUCTION TUBE TUBE, TONSIL SUCTION KCB UNKNOWN 0415222 (01)1088277122987

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention