It was reported that the gunther tulip filter retrieval set detached at hub and split at the sleeve when placed over the filter.This occurred during an ivc filter removal procedure.The site was not specified.According to the initial reporter, the procedure was completed via the "routine approach, no special circumstances." additionally, the patient did not experience any adverse effects due to this occurrence.Additional information regarding clarification of event details, patient anatomy and outcome has been requested, but is not available at this time.
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Investigation ¿ evaluation: a review of the complaint history, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.
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