(b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2019-00104; 3005168196-2019-00117.
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On (b)(6) 2018, the patient underwent a thrombectomy procedure in the right and left pulmonary artery using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8).It was noted that a left-sided pulmonary angiogram disclosed an occlusion of the proximal portion of the main pulmonary artery and a right-sided pulmonary angiogram disclosed significant superior and inferior, as well as, mid branch occlusions.The thrombectomy in the right pulmonary artery was completed with good results using a sep8 and a cat8.Upon removal of the sep8, the physician noticed that the tip of the sep8 was bent.Another thrombectomy was then completed in the left pulmonary artery with good angiographic results using a second sep8 and the same cat8.However, a perforation was noticed on the distal branch of the inferior left pulmonary artery which caused a pulmonary hemorrhage.The patient's respiration declined and the patient was intubated and transferred to the intensive care unit.A bronchial blocker was inserted via endotracheal tube with bronchoscopic guidance into the proximal bronchus of the lower lobe, where the pulmonary hemorrhage bleeding was identified and controlled.The patient then developed acute blood loss anemia, related to the pulmonary hemorrhage and the bleeding from the femoral arterial sheath removal.Therefore, packed red blood cells (prbc) were transfused emergently.The patient was then stable, the oxygen requirement was decreased to 60% on the ventilator, and heparin was restarted.Approximately eight hours post-procedure, the patient went into sustained ventricular tachycardia and ventricular fibrillation, most likely related to the ischemic right ventricle.The patient remained hemodynamically stable until an onset of arrhythmia.Cardiopulmonary resuscitation (cpr) was performed, but was not successful.The patient experienced hemoptysis after cpr began.Subsequently, the patient expired from ventricular tachycardia.The hemoptysis was reported to be a serious adverse event with a possible relationship to the indigo system and the index procedure.The sustained ventricular tachycardia was reported to be a serious adverse event with a possible relationship to the indigo system and the index procedure.
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