FindrWIRZ Guidewire System 의 안전성 경고

Safety alert

2016-11-23

2016-11-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20161123.html

Medical device safety alert: sentreheart findrwirz guidewire system medical device manufacturer, medimaps, has issued a medical device safety alert concerning its tbs insight [software version v.3.0.1]. the united states food and drug administration (fda) has issued medical device safety alerts concerning findrwirz guidewire system, manufactured by sentreheart [product code: 40-05; lot numbers: 01160568, 02160568 and 07160639-150; manufactured between 4 january and 22 july 2016]. the manufacturer is recalling the findrwirz guidewire system because the polytetrafluoroethylene (ptfe) coating may separate (e.G. peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. coating separation may be caused by issues with the device design or manufacturing processes. small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death. affected users are recommended to take the following actions: identify and stop using the affected products. return the affected products to the manufacturer immediately. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm530413.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm530336.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 november 2016.