MedSun Continues to Receive Reports About Unretrieved Device Fragments
MedSun: Newsletter #48, May 2010

MedSun continues to receive cardiovascular-related event reports that describe issues with Unretrieved Device Fragments (UDFs).

On January 15, 2008 FDA notified Healthcare Practitioners to a Public Health Notification entitled, "FDA Public Health Notification: Unretrieved Device Fragments", which informs providers of serious adverse events associated with UDFs and provides recommendations to mitigate these events.

A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to UDFs. These have included more than 200 different medical devices and numerous medical specialties. To view recent cardiovascular-related UDF reports submitted by MedSun facilities, see links under Addition Information below.

Additional Information:

MedSun Report. March 4, 2010. Available online.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D7%3C%27O%40%20%0A&CFID=36277908&CFTOKEN=af843cf573b3ec4-9BC134

MedSun Report. October 28, 2009. Available online.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D3%3F%26%5FP%20%0A&CFID=36277908&CFTOKEN=af843cf573b3ec4-9BC134

FDA Public Health Notification: Unretrieved Device Fragments. FDA Medical Device Safety. January 15, 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062015.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun