(b)(6).Device evaluated by mfr: the device was returned for evaluation.A stuck guidewire was in the device.The guidewire was attempted to be removed from the catheter; however, the wire would not exit.The devices shaft showed damage in the form of a fracture located 26.5cm from the hub.The fracture looked to be consistent with a tensile force breaking.The inner liner was also buckled.The device was not completely separated, the inner liner was still attached.The device was x-rayed to verify any internal damage that may cause the guidewire sticking.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
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Reportable based on device analysis completed on 18feb2022.The target lesion was located in the liver.A direxion catheter-infusion was selected for use.During the procedure, it was noted that the guide wire was stuck by the y valve of the microcatheter and could only be delivered in part of it.The procedure was completed with another of same procedure.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that the shaft showed damage in the form of a fracture located 26.5cm from the hub.
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