November 2007, Volume 37 Number 11 , p 17 - 17
Fischer, Robert A. RN, MSN
Robert A. Fischer is an anesthesia and central venous catheter device nurse-consultant at the Center for Devices and Radiological Health. Although you need to support your health care facility's adverse event–reporting policy, you may voluntarily report a medical device that doesn't perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178) or online at http://www.fda.gov/medwatch/how.htm . The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, who coordinates Device Safety , is a nurse-consultant at the Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md.
DURING A CARDIAC catheterization, a fractured guide wire lodged in a coronary artery, causing coronary artery perforation. Attempts to retrieve it failed, and the patient died from ...