Description

The BARD® PTFE Felt Pledget is an essential tool in the surgical field, crafted by BARD Peripheral Vascular, Inc., a BD company. This device is designed to provide reliable support during various surgical procedures, ensuring the integrity of sutured tissues.

Key Features

• Material Composition: Made from 100% polytetrafluoroethylene (PTFE) felt, this pledget is non-absorbable and intended for single use. Its non-woven, synthetic structure offers durability and resilience.

• Primary Function: It serves as a buttress under sutures, preventing them from tearing through tissue. This makes it invaluable in procedures involving vascular closure, septal repair, myocardial closure, hepatic repair, and valvular suturing.

• Tissue Reinforcement: The pledget reinforces suture lines and strengthens weak or injured cardiac and peripheral vascular tissues, providing peace of mind to surgeons.

Specifications

• Shapes and Sizes: Available in various shapes such as rectangles, squares, ovals, and rounds. Common sizes include 4.8 mm x 6.0 mm rectangles and 6.0 mm diameter rounds, among others. Custom sizes may be available upon request.

• Color: White

• Packaging: Typically packaged with 10 pledgets per sterile pouch and 25 pouches per box, ensuring a total of 250 units per box.

Sterilization and Handling

• Sterilization Method: Each pledget is sterilized using ethylene oxide (EO/EtO) and is supplied in a sterile condition. It is not intended for resterilization or reuse.

• Handling Precautions: Care should be taken to minimize handling to avoid contamination. Atraumatic instruments are recommended to prevent damage to the material.

Safety and Compatibility

• Biocompatibility: The pledget is not made with natural rubber latex, reducing the risk of allergic reactions. It complies with ISO-10993 biocompatibility standards, with results available upon request.

• Precautions: Ensure secure knots if used as a permanent ligature. Avoid using the pledget if the packaging is opened or damaged. Store in a sterile environment and adhere to the instructions provided in the package insert.

Potential Complications

Users should be aware of potential complications such as implant bleeding, infection, and tissue erosion, which are common risks associated with extrinsic implant devices. Proper surgical technique and adherence to guidelines can mitigate these risks.

The BARD® PTFE Felt Pledget stands as a reliable, high-quality surgical device, contributing to successful outcomes in complex tissue repair and cardiovascular procedures.