From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Hemorrhage is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2015-01128; 3005168196-2015-01129; 3005168196-2015-01130.Hospital disposed of the device.
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The patient was undergoing a thrombectomy procedure in the right middle cerebral artery using a penumbra system 5max ace reperfusion catheter, a penumbra system 5max separator, a penumbra system 3max separator and a velocity delivery microcatheter.During the procedure, the physician successfully removed thrombus and revascularization was established.However, a 24-hour post procedure non-contrast computerized tomography (ncct) scan revealed minimal patchy hemorrhage within the putamen.The patient was discharged home on (b)(6) 2015 and was doing well during a follow-up visit a month later.The reported hemorrhage resolved on (b)(6) 2015 without further intervention.The reported hemorrhage was determined to be of moderate severity with possible relationship to the penumbra system and the angiographic procedure.
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