A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The blue sheath and the black catheter were returned.The sheath has separated from the fitting.The measurement of the sheath flare is in accordance with manufacture instruction.The fitting was compared to a test-device and the complaint device is assessed to comply with the requirements.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The reported event is considered off-label use since the retrieval system was used for retrieval of a non-cook filter.Since the reported event is off-label use, no further action is warranted.
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