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 09/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The biosense webster, inc.Product analysis lab received the device for evaluation.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.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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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.While advancing the catheter through the vizigo¿ sheath, there was blood leaking back through the hemostatic valve.The vizigo¿ sheath was replaced and the issue resolved.The procedure continued.There was physical damage on valve/hub.The inner white component within the valve/hub became dislodged when trying to advance a catheter through the vizigo¿.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve become detached from the sheath within the hub housing.Air did not enter the patient¿s body.The issue did not require percutaneous, surgical removal, nor medical intervention.Patient hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost was not noted by the physician.The hemostatic valve separation was assessed as mdr reportable.
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Manufacturer Narrative
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The device evaluation was completed on 30-sep-2022.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.While advancing the catheter through the vizigo¿ sheath, there was blood leaking back through the hemostatic valve.The vizigo¿ sheath was replaced and the issue resolved.The procedure continued.There was physical damage on valve/hub.The inner white component within the valve/hub became dislodged when trying to advance a catheter through the vizigo¿.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve become detached from the sheath within the hub housing.Air did not enter the patient¿s body.The issue did not require percutaneous, surgical removal, nor medical intervention.Patient hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost was not noted by the physician.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.This issue could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; however, this could not be conclusively determined.The issue reported by the customer was confirmed based on the picture received.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 00002035 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.Manufacturer's reference number: (b)(4).
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