China-based Bioptimal International removed the heparin coating from the tubing for its thermodilution catheter without seeking FDA clearance for the device, earning the company a Warning Letter following a Nov. 6, 2023, inspection of the company’s Singapore facility.

Removal of this coating, the FDA letter says, “can lead to increased blood clotting and/or thrombus, which can result in embolization during clinical use, significantly impacting patient safety.”

The Warning Letter also describes Bioptimal’s marketing of a pulmonary artery catheter and claims this device maintains the same design as the cleared thermodilution catheter. However, based on the information gathered during the inspection, the letter states, “it appears the Pulmonary Artery Catheter has several technological characteristics that differ from the cleared Thermodilution Catheter,” primarily in the lumen design and in removal of a thermistor — a resistor that changes resistance based on temperature.

The company’s complaint handling procedure also lacks a method to evaluate incoming complaints “to determine whether the complaint represents an event which is required to be reported to FDA,” the letter says. Complaint record keeping lacked the name of the device, the date the complaint was received, the Unique Device Identifier (UDI), and the name, address, and phone number of the complainant.

Read the Warning Letter here.

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