(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Same case as mdr id: 2134265-2017-02512.It was reported that a hemostasis valve leak and death occurred.A left atrial appendage (laa) closure procedure was performed.A watchman® access system and a pigtail catheter were positioned in the laa.The implantation was described as challenging.The hemostasis valve could not be closed.Blood loss/leakage of one and half liters or more (ha to 6 gr) occurred despite numerous handlings.The access system was exchanged for a second access system after about an hour.However, the same issue occurred and the hemostasis valve could not be closed on the second access system.There was less blood loss.The patient needed a blood transfusion and treatment with a vaso active agent.The patient was in reanimation with a very serious problem.The patient was in the intensive care unit and in critical condition.Approx 6 days post procedure, the patient expired.The cause of death is not known.
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