The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.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 number: 3005168196-2019-00405.
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On (b)(6) 2019, the patient underwent a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8).During post procedural recovery, the patient began coughing up blood with clots and experienced hemoptysis.The patient¿s heparin drip was discontinued, and the hemoptysis was resolved on (b)(6) 2019.The hemoptysis was reported to be a non-serious adverse event with a definite relationship to the indigo system and a definite relationship to the procedure.
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