Device evaluated by mfr: the device was received for analysis after decontamination; the upn and lot number match those provided by the customer.The returned device has a bend located approximately 16 mm from the distal tip, which is proximal to ring three.Each of the rings around the mini electrodes appears to be cracked.In addition to the crack, a section of the ring around mini electrode three appears to be missing.Continuity checks revealed no electrical opens or shorts; all electrode, thermistor, and sensor resistance measurements were within specification.The steering knob and tenstion control knob functioned properly in both lock and unlock positions.No abnormal resistenace was felt when actuating the steering mechanism.Ablation was verified using a maestro generator 4000 and metriq pump and the device was found to be within specification.X-ray revealed a bend in the center support.Tip motion was evaluated and the device passed both the right and left curve tests.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).
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Reportable based on analysis completed march 07, 2018.It was reported an intellatip mifi¿ oi ablation catheter was selected for use.The catheter had a kinked tip and noise was observed on multiple mifi electrograms.The procedure was completed with another catheter and there were no patient complications.However, returned device analysis revealed a section of the ring around mini electrode three was missing.
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