It was reported that an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The hemostatic valve was damaged.It was reported that dilator of the vizigo sheath would not advance into the sheath.The sheath was replaced twice, and the case continued without patient consequences.The root cause of the issue was sheath related; carto 3 system is operating per specs.The resistance they were having with the sheath was when they were trying to put the dilator into the sheath.The valve on the sheath was damaged, the reporter assumes that this was caused by the dilator.Irrigation of the sheath was not attempted, the issue occurred during setup of the room, no patient or physician were present.No damage on the sheath itself was noticed, the issue occurred at the valve.The dilator could not be moved into the sheath.The dilator was not stuck in the valve, reporter states that it was easy to remove.Obstructed sheath is not mdr-reportable.Hemostatic valve separation is mdr-reportable.This report is for one of the two reportable sheaths.The other sheath was reported in manufacturer report number 2029046-2021-02221.
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The product investigation was completed.The product was returned to biosense webster 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 found dislodged inside of hub of the vizigo sheath.The dilator was found in normal condition.Microscopic examination in the hemostatic valve surface and showed evidence of stress marks on the outer diameter.On the other hand, the brim cap and the silicone ring were placed in the correct position and found in good conditions.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 dislodged into the hub.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, the stress marks, and physical damage observed 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 was performed for the finished device 00001751 number, and no internal actions related to the complaint were found during the review.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Due to 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).
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