On an interventional vascular order form, “6 × 80 mm” is not enough on its own. The same line should also say whether the device is a balloon or a stent, whether it is drug-coated, which wire diameter it accepts and which sheath it fits. This information appears in separate tables in the instructions for use (IFU). The clinical team chooses the size from the anatomy; purchasing and the warehouse match the same line to barcode, lot and unique device identification (UDI). If the size is right and the compatibility is wrong, the error appears on the day of the procedure. This article summarises how size and compatibility data are taken from the IFU and transferred to the supply checklist.
The IFU size table: the basis of the order
The instructions for use (IFU) contain the intended use, the warnings and the size tables. A summary in a brochure does not replace that table. An interventional IFU usually brings these facts together:
- Available diameters and lengths: The combinations the manufacturer offers, in millimetres.
- Compliance chart: The diameter the balloon reaches at different pressures. Nominal pressure and rated burst pressure (RBP) are given in atmospheres (atm).
- Compatible guidewire: The largest wire diameter that can be used, in inches.
- Compatible sheath: The smallest sheath the device will pass, in French (F).
- Shaft length: The usable length of the catheter, in centimetres. It is chosen from the distance between the access site and the lesion.
The IFU revision date is checked at every delivery. If the IFU of the lot in stock differs from the revision on the institutional record, the compatibility list may have changed. The general review order of a technical file, and the UDI headings, are described in the medical device technical file.
Diameter and length: balloon and stent
On a peripheral-artery lesion, the fields most often mixed on a PTA balloon or peripheral stent order are the diameter–length pair. Diameter is chosen from the healthy vessel next to the lesion (the reference vessel). Too small a choice leaves an inadequate lumen; too large a choice can cause dissection or vessel injury. Length is set to cover the lesion.
Three values read from the balloon IFU:
- Nominal diameter (mm): The diameter the balloon reaches at nominal pressure.
- Balloon length (mm): The working length of the balloon body.
- Nominal pressure and RBP (atm): RBP is the upper limit to which the balloon can be inflated safely. High-pressure models for calcified lesions are a separate product line.
For a stent the rule depends on the device type. Self-expanding stents are usually chosen 1–2 mm larger than the reference vessel and apply a continuous radial force to the wall. Balloon-expandable stents are opened to the target diameter by the balloon. The same millimetre figure means something different in the two stent types. Stent type is therefore a separate field on the order line. The clinical approach for balloon versus stent is in peripheral balloon or stent, and the abbreviations in angioplasty product groups.
Drug-coated balloon (DCB) and size
On a drug-coated balloon, diameter and length are written in the same way as on a plain PTA balloon. The IFU also states the drug (paclitaxel or sirolimus) and the dose density (µg/mm²). If the order says only “balloon”, a non-drug model can be sent. Device class (PTA, DCB, stent) is therefore a separate field on the order form.
Compatibility: wire, sheath and delivery system
Even when the size is right, an incomplete compatibility line means the set is not complete on the day of the procedure. Guidewire diameter is given in inches: 0.014, 0.018 or 0.035 inch. Converting that value to millimetres in the warehouse code, or writing only “wire”, can select the wrong device.
In an over-the-wire (OTW) system the wire runs the full length of the catheter. In a rapid-exchange (RX) system the wire passes only through the distal segment, which allows a shorter wire. In both systems the wire diameter in the IFU is an upper limit; a thicker wire will not enter the catheter. For the sheath, what matters is the largest-profile device that will pass the same access.
In a carotid procedure the stent, the embolic protection device and the sheath are separate product codes; compatibility is checked against the list of compatible devices in the stent IFU. On aortic grafts, proximal neck, main body and iliac limb sizes are separate fields. That split is summarised in the carotid, EVAR and TEVAR glossary.
The order line: order of entry
When an interventional line is filled in this order, the clinical team and the warehouse work from the same information:
- Anatomical territory: Peripheral, carotid, abdominal aorta or thoracic aorta.
- Device class: PTA balloon, DCB, stent, stent graft or embolic protection device.
- Size: Diameter × length (mm), shaft length (cm). On a graft, neck, body and limb sizes in separate columns.
- Compatibility: Wire diameter (inches), sheath size (F), delivery-system code.
- UDI and lot: At goods-in, comparison of the order, the delivery note and the device label.
In chronic limb-threatening ischaemia (CLTI) the below-knee vessels are small, so balloons and stents for that segment are stocked separately. The relation of perfusion and the wound is described in critical limb ischaemia and wounds. The order of medical and endovascular treatment is in the medical and endovascular pathway in peripheral artery disease.
Common errors
Writing only “6 mm” on the order and receiving a stent instead of a balloon, skipping shaft length across series of the same brand, and failing to separate thoracic from abdominal on a graft order are frequent in warehouse records. Another error is treating nominal pressure as the upper limit instead of RBP. Comparing diameter, length and lot on the outer carton and the inner pack, before the sterile pack is opened, reduces surprises in the procedure room.
Stock depth follows the institution’s case volume. Femoropopliteal and below-knee segments need different size ranges, so they are not run from a single “standard size” list. Product scope is listed on the angioplasty page.
Sources
- Mazzolai L, et al. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J. 2024. doi:10.1093/eurheartj/ehae179
- Conte MS, et al. Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. J Vasc Surg. 2019. doi:10.1016/j.jvs.2019.02.016
- Wanhainen A, et al. ESVS 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019. doi:10.1016/j.ejvs.2018.09.020
- ISO 15223-1:2021. Medical devices — Symbols to be used with information to be supplied by the manufacturer. iso.org
- VascularVita: Medical device technical file · Angioplasty product groups · Peripheral balloon or stent