The device was discarded by the customer, so specific device evaluation cannot be performed.However, based on our knowledge of the device design and its prescribed use, the most likely scenario is that the user removed the marker applicator separately from the biopsy probe.Tip shear has been identified as a potential risk whenever the applicator shaft is removed separately through the biopsy probe once it has been positioned in the probe aperture for marker deployment.Our biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the applicator shaft after exposure to the probe aperture creates the possibility of the applicator catching on one of these edges and shearing.As a mitigation step to address this risk, we provide warnings and precaution language and instruction within the instructions for use: warning: failure to align the mammomark applicator as specified may result in improper deployment of the collagen plug and possible tip shear.Warning #10: remove the mammomark applicator and the mammotome biopsy probe together as a single unit from the site and obtain images to confirm marker placement.At this time patient follow-up information is not available.However, due to the potential for a subsequent procedure or other treatment intervention, we are submitting this medwatch report.
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