E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically analyzed for damage.The device showed a fracture located 23.7cm from the hub.No other damage was noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was confirmed for a fracture.
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Reportable based on device analysis completed on (b)(6) 2024.It was reported that the catheter had damaged during unpacking.A 135/10 renegade hi-flo kit was selected for hepatic arterial chemoembolization.During unpacking, it was noted that the catheter had damaged and could not be used.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.However, device analysis revealed a fracture located 23.7cm from the hub.
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