Bard Peripheral Vascular, a subsidiary of Becton, Dickinson and Co., has reported 30 serious injuries and four deaths linked to the device due to a potential risk of helix fractures or breakages during use, according to an Feb. 6 news release from the agency.
The FDA alert follows a letter from Bard Peripheral to affected customers, outlining updated instructions to minimize risks. The company identified certain patient anatomical factors such as vessel size and calcification as well as procedural issues including catheter advancement, which can contribute to device failure.
These failures may lead to severe complications, including bleeding and death, requiring retrieval of broken catheter fragments.
The company also recommended several actions for healthcare providers, including reviewing the updated electronic instructions for use, attending online training and ensuring the use of appropriate sheaths and monitoring techniques during procedures.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
