BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER
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Model Number D138502 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2022 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) 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 valve on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was leaking blood, the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue was resolved.The case continued.Additional information was received.It was confirmed that hemostatic valve at the insertion site was leaking back with blood due to a section of the valve have broken off into the hub.A portion of the gasket was inside the hub.The hemostatic valve did not dislodge outside the hub.The brim cap/hub did not detach from the sheath.They did not take any picture of the malfunction valve, but the account has the sheath ready to ship out once they get the biohazard kit.The sheath was used on the patient during the exchange between the sl1 to the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium that¿s when the physician noticed the valve had blood bleeding back.No air was introduced into the patient during that time.No blood return was observed because only a couple of ccs of blood was lost during the valve malfunction.The approximate volume of blood that was lost was around couple of cc.The event was assessed as mdr reportable for a hemostatic valve separation issue.
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Manufacturer Narrative
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The bwi product analysis lab received the device for evaluation on 26-oct-2022.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) 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 valve on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was leaking blood, the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue was resolved.The case continued.Additional information was received.It was confirmed that hemostatic valve at the insertion site was leaking back with blood due to a section of the valve have broken off into the hub.A portion of the gasket was inside the hub.The device evaluation was complete on 12-nov-2022.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 are performed during insertion with the dilator, outside of what is recommended in the odp (optimal device performance guide).A device history record was performed for the finished device batch number, and no internal actions were identified.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.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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