Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information reviewed, a conclusive cause for the reported unstable hemostatic valve could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.
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This is being filed to report unstable component.It was reported that during preparation of a steerable guide catheter (sgc), the rotating hemostatic valve (rhv) on the dilator would not properly close due to the rhv seemed loose.The sgc was not used in the patient.Due to complications with the transseptal puncture, the procedure was aborted.There was no patient involvement and no reported clinically significant delay in the procedure.No additional information was provided.
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