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.
