The mammomark biopsy site identifier is intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the marker delivery system separately from the probe aperture once the spring is exposed creates the possibility of it catching on one of these edges.As a mitigation step to address this risk, we provide instructions within the instructions for use: directions: remove the delivery system and mammotome probe together as a single unit from the site, properly dispose and obtain images to confirm marker placement.Based on the patient consequence of an unintended piece of the device in the biopsy site, and the additional surgical procedure to remove, and pursuant to 21 cfr 803, we are submitting this medwatch report.
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Devicor medical products, inc.Received a report from our affiliate, (b)(4), stating, during the procedure the drop button was hard to use and defective so the tip of the marker applicator has been stuck in the aperture of the probe and cut during pulling back to remove from the probe.The tip of the marker applicator is inside the patient's breast.The patient is scheduled to have surgery to remove the cancerous lesion revealed by the vacuum assisted biopsy procedure; the applicator tip will be removed at that time.The patient has not complained of any secondary effects.This has been documented in our system as record # (b)(4).
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