Initial reporter phone: (b)(6).The product was returned to biosense webster (bwi) for evaluation.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside the hub component.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The stress marks suggest that excessive force or manipulation was applied due to an extreme off axis angle of insertion.Valve dislodgement occurs when extreme off axis angles is performed during insertion with the dilator, outside of what is recommended in the odp (optimal device performance guide).A device history record evaluation was performed for the finished device number 50000135 and no internal action was found during the review.The issue reported by the customer was confirmed.The odp 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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system this report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
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It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred.It was reported that the hemostatic valve was broken.The hemostasis valve (gasket) was not dislodged inside or outside the hub, no dislodgement was observed, just leaking.The brim cap/hub did not become detached from the sheath.Air did not enter the patient¿s body and the approximate volume of blood that was lost was 50ml.No adverse patient consequence was reported.The hemostatic valve separation issue was assessed as mdr reportable.
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