Block h6: medical device problem code a15 captures the reportable event of clip difficult to detach from catheter.Block h10: investigation results.The returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly and with evidence of premature deployment (yoke was attached to the control wire).The device was returned without the over-sheath.Microscopic examination was performed and it was confirmed that the device had evidence of premature deployment.Additionally, the bushing had hit marks.Dimensional examination was performed on the bushing outer diameter and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and both sides were noted to be within specification.No other problems with the device were noted.The reported event of clip difficult to detach from catheter was not confirmed.Investigation found that the yoke was returned attached to the control wire, this is likely due to operational factors during the procedure such as trying to open the clip once it was already activated.Additionally, the hit marks found on the bushing is likely due to the interaction between the yoke and the capsule, in order to deploy the clip.However, the device was returned without the clip assembly and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take in consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification, excluding the possibility that the device components dimensions interfered with the device performance.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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