Devices

FDA Feeding Tube Placement Letter

FDA is giving healthcare providers information about reports of pneumothorax events associated with feeding tube placement procedures using enteral access systems. A MedWatch notice says most reports indicate the pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of the events were associated with cardiopulmonary arrest and patient death, FDA says.

From 1/2012 to 7/2017, the agency says, FDA received 51 Medical Device Reports (MDRs) about pneumothorax events related to the use of the Corpak Medsystems Cortrak 2 device. There also were 28 MDRs about events related to use of the Covidien Kangaroo device. For both devices, the notice says, the relationship between the pulmonary events and the death cannot be concluded definitively in all cases.

“Because the MDR system is based on passive surveillance,” the notice says, “FDA cannot determine how the rate of these complications compares to that estimated for blind insertion.”

The notice includes agency recommendations for enteral access systems in general, with additional recommendations for the Contrak 2 device in particular.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome