It was reported that during an ivc filter retrieval procedure using a gunther tulip vena cava filter retrieval set , they were able to snare the filter but in the process of attempting to remove the filter, the snare wire snapped in half (medwatch# 1820334-2017-00988).A second retrieval kit was used and the hub separated from the outer blue sheath (medwatch# 1820334-2017-00989).They were able to successfully complete the procedure with the second device.There were no reported adverse effects on the patient due to this occurrence.
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Additional information: a review of the complaint history, device history record, manufacturing instructions, specifications, quality control, instructions for use (ifu), and visual inspection of the returned device was conducted during the investigation.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 complete product was returned and the retrieval loop appeared used.A tear was found at the distal tip of the black 6.3fr inner catheter, probably caused by strong manipulation during attempts to remove the filter.The loop wire had separated in the transition between handle and shaft.A severe kink in the same area also indicates strong manipulation of the loop wire.Based on these findings, the breakage is considered procedure-related and reference is made to the ifu stating that excessive force should not be used to retrieve the filter.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
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