Epidural conduction device fractures and complications of retained fragments.
During the past 3 years, the US Food and Drug Administration (FDA) has received a growing number of adverse event reports on the breakage or fracturing and retention of anesthetic conduction device tips with associated complications. Serious injuries and other problems such as spinal stenosis, nerve root compression, and subcutaneous effusion can result. Several case reports demonstrate how the problems occur; some illustrate the severity of the problem. All cases are from adverse event reports in the FDA Center for Devices and Radiological Health (CDRH) Manufacturer and User Facility Device Experience database. Frequently, in the interest of not causing patient harm, a device fragment might not be removed as long as the patient is not neurologically compromised or at risk for infection or there is little potential for migration of the fragmented piece. On many occasions, the fragments remain in patients without their knowledge. The FDA wants to raise awareness of the problem and its potential impact in creating complications, encourage the practice of informing patients of the fragmented device, and promote reporting of such incidents to CDRH via the MedWatch reporting system. Based on a search of the current literature, recommendations for prevention are suggested.
Fischer
Robert
R
Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Division of Postmarket Surveillance, Rockville, Maryland, USA. robert.fischer@fda.hhs.gov
D000767:Anesthesia, Epidural / Q000009:adverse effects* / Q000295:instrumentation* / Q000451:nursing; D001696:Biomechanical Phenomena; D002408:Catheters, Indwelling / Q000009:adverse effects*; D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D006801:Humans; D009719:Nurse Anesthetists; D010353:Patient Education as Topic; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D033081:Shear Strength; D013718:Tensile Strength; D014481:United States; D014486:United States Food and Drug Administration