(b)(4).Investigation: a review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The complete retrieval device is returned with the retrieved filter.Investigation revealed a 7 mm crack in the distal tip of the blue sheath and besides the tip being damaged, the sheath is compressed in more areas.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The findings suggest that the retrieval device was exposed to manipulation/strength beyond its intended design during attempts to collapse and retrieve the filter.However, based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the risk assessment, no further action is warranted.No harm to the patient was reported.Monitoring will continue to be performed for similar complaints.
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An international customer reported that, during an inferior vena cava filter retrieval, the blue sheath of a gunther tulip vena cava filter retrieval set buckled in three separate locations.The user was unable to advance a wire retrograde.Further information regarding the effect on the patient was requested, but not provided.
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