Diamondback 360 Peripheral Orbital Atherectomy System 의 안전성 경고

Safety alert

2014-08-20

2014-08-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140820b.html

Medical device safety alert: cardiovascular systems, inc. diamondback 360 peripheral orbital atherectomy system the united states food and drug administration (fda) has issued a medical device safety alert concerning diamondback 360 peripheral orbital atherectomy system [model number: dpb-125micro145; part number: 7-10003; lot numbers: 100573, 100575, 100674, 100676, 100678, 100680], manufactured by cardiovascular systems, inc. ninety-four affected devices were manufactured from 05/08/2014 to 05/09/2014. forty-eight devices were distributed from 05/16/2014 to 05/20/2014. according to the fda, the manufacturer is recalling certain lots of the diamondback 360 peripheral orbital atherectomy systems because they may contain defective saline sheaths that could fracture during use. if this happens, fragments of the sheath could possibly block the blood vessel under treatment or blood vessels further away (cause an embolism). there are no reported patient injuries to date. on may 27, 2014, the manufacturer sent an “urgent medical device recall” letter to their customers. the letter identified the problem and the specific products affected by the recall. the letter advises customers to: remove affected devices from service. complete and return a “customer acknowledgement form.” return affected devices to cardiovascular systems. for details, please refer to the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm410527.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm410449.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2014.