📋 FDA Reference
Pounce Sheath
Summary: The Pounce Sheath by Surmodics is a medical device used in embolization procedures, typically by interventional radiologists. It is designed to facilitate the delivery of embolization coils to target sites within the vascular system.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K231828 ↗
Decision Date ?
September 7, 2023
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Pounce Sheath was cleared through the FDA's 510(k) pathway on September 7, 2023. It is manufactured by Surmodics and classified as a Class 2 medical device.
What It Is
The Pounce Sheath is a specialized medical device used to assist in the delivery of embolization coils during vascular procedures. It functions as a conduit, allowing clinicians to navigate through the vascular system to deliver therapeutic agents precisely. This device is particularly useful in procedures where precise placement of embolization materials is critical to occlude blood vessels and control bleeding.
FDA-Cleared Indications
- Delivery of embolization coils for the occlusion of blood vessels.
- Use during endovascular procedures in which controlled vascular embolization is indicated.
Clinical Applications
- Catheter-based delivery of embolization coils to selected blood vessels.
- Embolization of aneurysms or pseudoaneurysms when coil occlusion is indicated.
- Embolization to control bleeding from selected vascular branches.
- Embolization of abnormal vascular connections, such as arteriovenous malformations, when coil therapy is appropriate.
Reported off-label uses
- Delivery of embolic materials other than coils when the device's size, compatibility, and labeling permit clinical use.
- Delivery of coils in selected venous embolization procedures, such as treatment of varicoceles or ovarian vein reflux, when determined appropriate by the treating physician.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The available sheath sizes and lengths should be matched to the target vessel, access route, guidewire, catheter, and embolization coil system.
- Use requires fluoroscopic or other appropriate imaging guidance and clinicians trained in vascular access, catheter navigation, and embolization.
- Confirm compatibility with the intended embolization coils and delivery system before the procedure; device compatibility is not universal across all products.
- MRI safety should be confirmed in the current manufacturer labeling. Do not assume that the sheath or any retained embolization material is MRI safe or conditional without checking the specific product information.
- Potential complications relate to vascular access, catheterization, and embolization, including bleeding, vessel injury, non-target embolization, infection, thrombosis, and ischemia. Contraindications and warnings should be reviewed in the current FDA-cleared labeling.
Procedures that use this device
Frequently Asked Questions
What is the Pounce Sheath used for?
The Pounce Sheath is used to deliver embolization coils to occlude blood vessels during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Pounce Sheath.
What are the FDA-cleared indications?
The FDA-cleared indications include delivering embolization coils to occlude blood vessels in procedures like aneurysm treatment or hemorrhage control.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.