BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER
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Model Number D138502 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref (b)(4).
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Event Description
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It was reported that a patient underwent a persistent atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve leak occurred.It was reported that the valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was malfunctioning and leaking blood.The vizigo¿ was replaced and the issue was resolved.The case continued.There was no patient consequence reported, as such, this event is being reported as a product malfunction.
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Manufacturer Narrative
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It was reported that the valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was malfunctioning and leaking blood.The vizigo¿ was replaced and the issue was resolved.The case continued.There was no patient consequence reported.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device 50000047 number, and no internal actions related to the complaint was found during the review.Still no device has been received for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Based on the completed mre, the h4.Device manufacture date has been populated with 30-oct-2021.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Search Alerts/Recalls
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