S Cath™ System Suprapubic Foley Catheter with Introducer Set 10cc 42cm
S-Cath™ (Mediplus)
Medical device — Suprapubic Foley catheter kit (introducer / Seldinger)Suprapubic catheterisation introducer kit with silicone Foley catheter (Seldinger technique)
Certifications
- CE Marked (manufacturer documentation and NICE advice note CE conformity for the S Cath System; historical Class IIb CE certification noted in NICE assessment).
- Recommended by NICE (NICE MIB68 advice) and noted as approved by the British Association of Urological Surgeons (BAUS) in manufacturer and independent literature.
- Winner of the Queen's Award for Innovation (2017) — manufacturer recognition and product awards listed on official sources.
- CE Marked (manufacturer documentation and NICE advice note CE conformity for the S Cath System; historical Class IIb CE certification noted in NICE assessment).
- Recommended by NICE (NICE MIB68 advice) and noted as approved by the British Association of Urological Surgeons (BAUS) in manufacturer and independent literature.
- Winner of the Queen's Award for Innovation (2017) — manufacturer recognition and product awards listed on official sources.
Suprapubic catheterisation introducer kit with silicone Foley catheter (Seldinger technique)
Description
The S-Cath™ System is a sterile, single-patient suprapubic Foley catheter kit that uses the Seldinger technique (patented 3-stage guidewire) to enable controlled, accurate placement of a silicone Foley catheter into the bladder. The complete kit (introducer set) typically contains a puncture needle, 3-stage guidewire, sheath/dilator, silicone Foley catheter with integrated balloon (10cc balloon volume in this presentation), scalpel, and syringes. The system is intended for outpatient and inpatient suprapubic catheterisation by trained clinicians and aims to reduce trauma and increase placement accuracy compared with blind insertion techniques.
Bnefits
- Greater control and accuracy using the Seldinger technique and patented 3-stage guidewire compared with blind suprapubic insertion.
- Complete, single sterile kit that can be used in outpatient settings to save time and resource use vs inpatient procedures.
- Minimises tissue trauma and reduces risk associated with blind insertion techniques.
- Versatile range of sizes (commonly 8Fr–16Fr) and tip options (open or closed) with integrated balloon and radiopaque stripe for positioning.
- Widely recommended and recognised — cited by NICE advice and approved by BAUS; recipient of the 2017 Queen’s Award for Innovation.
Indications
- Placement of a suprapubic catheter for bladder drainage when urethral catheterisation is contraindicated, not possible, or inappropriate.
- Replacements/exchange procedures (specific exchange kit available) and use in adults and children where anatomically appropriate and clinician-judged.
Composition
- Silicone Foley catheter (medical grade silicone) with integrated inflation balloon (10 cc volume in the specified presentation).
- Introducer components: metal puncture needle, multi-stage guidewire (patented 3-stage design), peel-away sheath/dilator, scalpel and disposable syringes (one syringe may contain glycerine solution for balloon inflation in some kit variants).
- Packaging and traceability labels included for lot/batch control.
Formulation
- Sterile kit supplied for single-patient use; components are provided sterile and sealed in tray/pack.
- Catheter lengths commonly include 33 cm (8Fr) and 42 cm (12–16Fr) variants; specified product here is 42 cm length with 10 cc balloon.
- Tip options: open and closed tip catheters available (8Fr typically closed tip only).
Packaging
- Complete sterile kit boxed with a single prepacked sterile tray containing catheter (in sheath), introducer components (needle, guidewire, dilator), scalpel, syringes and instructions for use (IFU).
- Outer carton labelled with product name, size (Fr), catheter length, balloon volume, lot/batch number, expiry date and manufacturer details.
Usage
- For insertion by trained clinicians familiar with suprapubic catheterisation and the Seldinger technique; follow the manufacturer's IFU and local clinical protocols.
- Perform under appropriate anaesthesia/analgesia and aseptic conditions; use ultrasound guidance where indicated to identify bladder and avoid bowel.
- Follow stepwise Seldinger technique using needle puncture, guidewire insertion, dilator/sheath placement and catheter advancement; inflate balloon with the recommended volume (10 cc) and confirm placement by urine drainage and/or imaging per local protocol.
- Dispose of single-use components after procedure and retain traceability labels as required.
Contraindications
- Uncorrected coagulopathy or significant bleeding diathesis unless corrected prior to procedure.
- Known or suspected abdominal wall infection at intended insertion site.
- Important contraindication where bladder is not distended or cannot be safely accessed (use ultrasound assessment).
- Relative contraindication in patients with prior lower abdominal surgery or anatomical abnormality — clinician judgement and imaging required.
Adverse Effects
- Insertion-related: bleeding, wound infection, urinary tract infection, local pain, haematuria and transient bacteriuria.
- Procedure risks: bowel perforation (rare but serious), catheter malposition, catheter blockage, balloon rupture or leakage, and skin irritation/extravasation at the insertion site.
- Long-term catheter-related: chronic UTI, encrustation, bladder spasms and potential for catheter migration or blockage.
Storage Conditions
- Store in original packaging in a cool, dry place away from direct sunlight; follow manufacturer's recommended storage conditions and expiry date printed on pack.
- Do not use if the sterile packaging is damaged or opened prior to intended use.
Duration
Intended for temporary or long-term bladder drainage depending on clinical need; catheter dwell time and replacement intervals determined by clinical guidelines and patient care plan.
Onset
Immediate bladder drainage on successful catheter placement.
