It was reported that a patient underwent afib ¿ persistent ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred.It was reported that during the ablation procedure, they encountered a problem on the irrigation system of the vizigo¿ sheath.It was impossible to aspirate from the side port; however, flushing was still possible.Some blood leaked through a breach in the hub of the sheath and formed a clot.Hence, when aspirating through the side port, the blood clot got sucked into the tubing and obstructed it in such a way that it was impossible to aspirate any further.Sheath was then pulled out of the patient and several unsuccessful attempts of flushing/aspirating were made to get the blood clot out of the irrigation system.The sheath was replaced, and the procedure was successfully completed.There were no clinical consequences.The surgery was delayed by about five minutes due to the reported event.No fragments were generated.No other medical intervention was required.There was no patient consequence.Additional information was received on 6-jan-2022.It was reported that this issue is not linked to the ablation catheter nor to any radiofrequency (rf) application.The blood clot formed outside of the patient, in the hub of the sheath.The patient was anticoagulated, with act measurements performed every 30min throughout procedure, targeting values of 350-400.
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The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 11-mar-2022.The device evaluation was completed on 16-mar-2022.It was reported that a patient underwent afib ¿ persistent ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred.It was reported that during the ablation procedure, they encountered a problem on the irrigation system of the vizigo¿ sheath.It was impossible to aspirate from the side port; however, flushing was still possible.Some blood leaked through a breach in the hub of the sheath and formed a clot.Hence, when aspirating through the side port, the blood clot got sucked into the tubing and obstructed it in such a way that it was impossible to aspirate any further.Sheath was then pulled out of the patient and several unsuccessful attempts of flushing/aspirating were made to get the blood clot out of the irrigation system.The sheath was replaced, and the procedure was successfully completed.There were no clinical consequences.The surgery was delayed by about five minutes due to the reported event.No fragments were generated.No other medical intervention was required.There was no patient consequence.Additional information was received on 6-jan-2022.It was reported that this issue is not linked to the ablation catheter nor to any radiofrequency (rf) application.The blood clot formed outside of the patient, in the hub of the sheath.The patient was anticoagulated, with act measurements performed every 30min throughout procedure, targeting values of 350-400.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the hemostatic valve was missing from the hub of the carto vizigo sheath.For this reason, a guidewire was inserted through the sheath and the valve was not found inside the vizigo¿; the valve was separated from the device.Examination of the brim cap and the silicone ring revealed the components were placed in the correct position and found in good conditions, the shaft presented a bent near ring 4.An irrigation test could not be performed due to the lack of the hemostatic valve, the side port was inspected and dissected, and no obstruction nor thrombus was found.Blood was observed in the hub from the photo provided by the decontamination lab.This could be related to the presence of thrombus, even though we did not find any, they could have been washed by the disinfection process.A device history record (dhr) review was performed for the finished device 00001762 number, and no internal actions related to the complaint were found during the review.Based on other dhr, the h4.Device manufacture date has been updated.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.Based on the information currently available, a microscopic examination of the returned product indicates that the hemostatic valve was found separated from the hub.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the separation of the valve.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.Manufacturer's reference number: (b)(4).
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