On 6-apr-2022, bwi received additional information regarding the event.The damage did not result in wires being exposed or any lifted or sharp rings.The sheath was used on patient's body.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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On 21-apr-2022, the bwi product analysis lab received the device for evaluation.The product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.There was resistance when trying to advance the dilator through the vizigo sheath while prepping for the procedure.Device evaluation details: visual analysis revealed that the hemostatic valve was dislodged inside of hub component.The valve was broken in half, a microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The damage 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 suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.The sheath was perforated near the handle, as reported, this happened trying to overcome the resistance, the force applied then broke the shaft of the sheath.Due to the conditions of the hemostatic valve, an internal action was opened.A device history record review was performed for the finished device 00001885 number, and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.The odp (optimal device performance guide) contains the following caution: 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.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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