11/23/2023 0 Comments Carto bi![]() ![]() ![]() On, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that during an atrial fibrillation (afib) ablation procedure, while advancing the dilator through the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, the white hemostatic valve of the hub became broken and appeared to get detached.The sheath could not be flushed.The sheath was replaced, and the issue resolved.The issue occurred prior to sheath usage on patient.Case was continued.It was also reported that the carto 3 system displayed error 6101 (no ethernet communication is detected) and 6150 (magnetic sensor error) when the soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter was connected to the front of the piu.The cable was exchanged, and the issue persisted.The catheter was exchanged, and the issue was resolved.No patient consequences were reported.Device evaluation details: a visual inspection was performed and it was found that the hemostatic valve is dislodged inside the hub of the device.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve since stress marks and physical damage on the outer diameter were observed under microscope which suggest that excessive force was applied.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath.Always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.A device history record review was performed for the finished device 00001479 number, and no internal action related to the complaint was found during the review.The customer complaint was confirmed.The root cause of the dislodged hemostatic valve inside the hub could be related to handling of the device during the procedure however, this cannot be conclusively determined.The odp (optimal device performance guide) provide additional instructions on how to insert the dilator into the sheath.Due the conditions observed in the hemostatic valve conditions, an internal action was opened.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4). business intelligence and how much functionality should be developed within BI.
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