Alerta De Seguridad para OPTEASE Retrievable Vena Cava Filter

Safety alert

2013-10-16

2013-10-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016c.html

Medical device safety alert: cordis optease retrievable vena cava filter medical device manufacturer, cordis (a johnson & johnson company), has initiated a field safety corrective action concerning optease retrievable vena cava filter. the affected catalogue numbers are 466f210a and 466f210b, and the affected lot numbers are 15960131 and below. cordis has identified a printing error on one unit of optease retrievable vena cava filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. the error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. implant of the opteaser retrievable vena cava filter with the hook oriented in the cranial direction can result in life threatening or serious injury including, but not limited to dissection, vessel perforation, migration of the filter with secondary damage to cardiac structures and ineffective pulmonary embolism prevention. there is no impact to the patient if the physician has successfully deployed and subsequently retrieved the filter. the manufacturer advises users to immediately identify, set aside and return all the affected products. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to website of the medicine and healthcare products regulatory agency, united kingdom: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967 if you are in possession of the product, please contact your supplier for necessary actions. posted on 16 october 2013.