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); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that an unknown patient underwent an atrial flutter left (l-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium.There was fluid coming back through the hemostatic valve.There was resistance when trying to advance the dilator through the vizigo sheath and when flushing the sheath there was fluid coming back through the hemostatic valve.The vizigo sheath was exchanged, and the procedure continued.No patient consequences were reported.Hemostatic valve leak is mdr-reportable.Resistance with sheath is not mdr-reportable.
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Manufacturer Narrative
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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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Manufacturer Narrative
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On 1-feb-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 (b)(6) 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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