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.
|