It was reported that during a procedure, the flexor introducer sheath valve disconnected and the patient experienced significant blood loss.Additional information regarding the valve separation, patient's anatomy and outcome, and quantification of blood loss has been requested, but is not available at this time.
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Additional information: attempts were made for additional information regarding the valve separation, patient's anatomy, outcome, and quantification of blood loss; however this information was unable to be provided.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control, was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record noted two nonconforming events that were not related to the reported failure mode.All non-conforming product were scrapped or re-worked as appropriate.It should also be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
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