(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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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It was reported a hemostasis valve leak occurred.During a left atrial appendage (laa) closure procedure, it was noticed that the hemostasis valve of the watchman® access system was unable to be fully closed; therefore, creating a blood leak.No patient complications reported.
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