The c1535 micromark® ii tissue marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.The micromark ii tissue marker is a sterile, single patient use device comprised of a small stainless steel marker and a disposable introducer and applier.The introducer consists of a flexible tube, a distal ramp, and a lateral port.The applier consists of a flexible shaft, a deployment mechanism, and a handle.The marker is located at the distal end of the applier.The device has not been returned to the manufacturer for evaluation which prevents a full investigation and analysis of the root cause at this time.However, based on the instructions for use, the following could cause or contribute to reported event.Significant force to the applier handle when inserting device into probe for deployment.Removing the device independently from the probe when significant resistance is encountered.Twisting or kinking of the applier shaft.The treating physician indicated no fragments of the device remained in the patient.However, as the occurrence has the potential to result in patient consequence with the need for surgical intervention or other form of treatment, should fragments have been transferred to the patient and pursuant to 21 cfr 803, we are submitting this medwatch report.
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It was reported by the (b)(4) affiliate that during the procedure, the micromark was inserted into the probe but the doctor did not obtain image the marker was deployed.The micromark was changed and pulled back, the introducer of micromark was broken.It seemed that any piece of the flexible introducer is not left in the patient.
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