The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for the reported oad was unable to be reviewed, as the lot number was not provided.Csi id: (b)(4).
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The peripheral diamondback orbital atherectomy device (oad) became stuck, and during attempts to remove the oad, a small perforation occurred.The oad had to be surgically removed and the vessel was repaired.The target lesion was an extremely calcified posterior tibial artery (pt), that had 100% stenosis, and was not tortuous.The oad was operated successfully in the anterior tibial artery (at), balloon angioplasty was performed and then the oad was advanced towards the pt.Due to chronic total occlusion, the oad had trouble crossing and it was discovered that the device was not luminal and had became stuck in the pt.Multiple attempts were made to remove the device; the device was pulled back, the shaft was cut and they tried to move the device towards a catheter but they were unsuccessful.As a result a small perforation was noted while attempting to remove the device and the patient was sent to surgery to remove the oad.The vessel was noted to be torn up as well, and was repaired during surgery.
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