BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM.; INTRODUCER, CATHETER
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Model Number D138502 |
Device Problems
Fluid/Blood Leak (1250); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2022 |
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.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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Event Description
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It was reported that an unknown patient underwent an ablation; field preference ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.It was reported that the vizigo sheath's hemostatic valve was inspected broken, thus noticed backflow of blood from the sheath's hemostatic valve end.It was exchanged to a new vizigo sheath.No complication occurred and procedure continued.Surgery was not delayed due to the reported event.The procedure was successfully completed.No patient's consequence.The hemostatic valve was the section that broke/separated.It was dislodged inside the hub but not outside the hub.The brim cap/hub did not detach from the sheath.Item was disposed, hence no picture.The sheath was used on the patient.Air entered the patient¿s body.No complication.No treatment required as no complication occurred.Very small volume of blood backflow, probably around 10ml to 20ml before exchanged to new vizigo sheath.Hemostatic valve leak is mdr-reportable.
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Manufacturer Narrative
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On 25-may-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 50000008 and no internal action related to the complaint was found during the review.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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