E1.Initial reporter address 1: (b)(6).Only the main coil was returned for the analysis.Visual inspection revealed the main coil was stretched, detached and bent at the coil arm section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional inspection could not be performed due to only the main coil was returned for the analysis.The dimensional inspection revealed that the outer diameter (od) at the zap tip and primary coil were found to be within specification.
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Reportable based on the device analysis completed on (b)(6) 2023.It was reported that the coil was stuck in the catheter.The target lesion was located in the femoral artery.An 12mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that the coil was stuck in the middle of the catheter, the coil could not be pushed out.During the operation, water flushing was applied, but it still could not be relieved.The device was removed together with the catheter.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that the main coil was detached.
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