Patient information unavailable.Device model, lot number, expiration date and udi unavailable.Physician name, phone and email unavailable.510k unavailable because device model and lot numbers unavailable.Device manufacture date unavailable because lot number unavailable.
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The manufacturer was made aware on 12 sept 2020 of a literature review performed by (b)(6).This report has been submitted to capture an adverse event described in the journal article from, 'chin j gen surg, august 2019, vol.34, no.8', entitled, 'excimer laser atherectomy combined with drug-eluting balloon for lower limb arteriosclerosis obliterans'.According to the article, the clinical data was retrospectively analyzed of 42 patients with lower limb arteriosclerosis obliterans, who underwent excimer laser atherectomy (ela) + drug coated balloon (dcb) from sep 2016 to dec 2018 in the department of vascular surgery of beijing hospital.In the article, the event date was not documented; therefore the date of 1 sept 2016 was chosen to capture the earliest time frame in which the patients underwent the procedures.In this procedure applicable to this report, a spectranetics turbo elite laser atherectomy catheter was reportedly used.Concomitant devices were reportedly used during the 42 procedures as well, but the article did not specify which of the devices was used to treat this patient's lesion.The article went on to state that after ela was performed, an embolization reportedly occurred in the patient's anterior tibial artery and a balloon with a diameter of 3 mm (biotronik, germany) was used to dilate the occluded vessel segments and then the distal blood flow was restored.The patient survived the procedure.There was no alleged malfunction of the turbo elite device in use during the procedure.
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