Batch history review: the manufacturing file was reviewed.It is compliant with the specifications and no abnormality was detected during production.Another similar complaint has been reported on the same vena cava filter batch by the same reporter (9612452-2018-00038).This batch has been sold since may 2016.Investigation: the involved device is not available for investigation; the filter is still implanted in the patient's body.The received xray pictures show that : -the filter was placed via jugular approach.-one filter leg is in a horizontal position.Another leg is slightly distorted.-the patient is correctly protected against pe.These x-rays do not allow us to determine the origin of the resistance encountered during the filter release.However the filter seems to have been pushed to be released while the ifu specify to withdraw the sheath towards yourself.Conclusion: the elements received do not allow us to determine why a resistance was encountered during filter progression inside the sheath.The review of the films confirms that one filter legs is crossed.The complaint rate for this type of incident is inferior to 0.2%.No corrective action is envisaged.This seems to demonstrate that the filter was pushed to be released while the ifu request to hold the pusher in one hand, take the sheath in the other hand and under fluoroscopy, draw the sheath towards yourself.This movement deploys the filter.Remember: to ensure proper filter positioning, it is extremely important to not move the pusher: -after the filter is positioned for deployment.- during filter deployment.B braun medical (b)(4) has provided all the information currently available.In spite of all reasonable efforts being made to obtain further information, at this time we have not met with success.B braun medical (b)(4) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.
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