BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL; INTRODUCER, CATHETER
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Model Number D138501 |
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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(b)(6).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.(b)(4).
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Event Description
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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 ¿ small and a hemostatic valve separation issue occurred.The hemostatic valve was not attached.Because there was no hemostatic valve, the issue was resolved by changing the vizgo to another one.No adverse patient consequence was reported.The hemostatic valve separation issue is mdr reportable.
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Manufacturer Narrative
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Additional information was received on 02-nov-2022.It was reported that the hemostasis valve (gasket) did not dislodge inside nor outside the hub.The brim cap/hub did not become detached from the sheath.The sheath was not being used on the patient.No blood return was observed.A picture was received for evaluation.According to the picture provided by the customer, the hemostatic valve was missing from the sheath.A device history record evaluation was performed for the finished device number 00001985, and no internal actions related to the reported condition were identified.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate to find the root cause of the complaint.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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