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 08/02/2022 |
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 hemostatic valve of the vizigo¿sheath became dislodged and there was blood leaking.The white gasket was inside the hub dislodged.The gasket looked to remain intact.The sheath was in the patient when the problem occurred.No air entered the patient.The issue did not require surgical intervention just a sheath exchange.No hemodynamic instability was observed.Blood loss was minimal.The sheath was exchanged, and the issue was resolved, and the case continued without any further incident.No adverse patient consequence was reported.
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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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Manufacturer Narrative
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The device evaluation was completed on (b)(6) 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.It was reported that the hemostatic valve of the vizigo¿sheath became dislodged and there was blood leaking.The white gasket was inside the hub dislodged.The gasket looked to remain intact.The sheath was in the patient when the problem occurred.No air entered the patient.The issue did not require surgical intervention just a sheath exchange.No hemodynamic instability was observed.Blood loss was minimal.The sheath was exchanged, and the issue was resolved, and the case continued without any further incident.No adverse patient consequence was reported.Device evaluation details: the carto vizigo¿ sheath 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 (dhr) evaluation was performed for the finished device 50000171 number, and no internal action related to the complaint was found during the review.Based on the dhr, the h 4.Device manufacture date has been updated.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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