Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, it was observed that the sheath was reinserted into the left atrial side and air was being aspirated from the sheath port.It was also indicated that the dilator lock ¿felt weaker than usual.¿ the sheath was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the data files were returned and analyzed.The data files did not show system notices or issues for the date of the event.There was no indication of a product malfunction, and the sheath was returned for investigation.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Event summary: the patient data files showed fourteen injections were performed with catheter 2af284/59616-28 without any issues or system notices.Upon visual inspection of flexcath sheath 4fc12/47540-042, results showed the device was intact with no apparent issues.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.It was suspected that the valve disk was torn.This is a case related to a clinical issue (right bundle branch block) and air ingress.In conclusion, the reported air ingress issue has been confirmed through testing.The reported right bundle branch block cannot be confirmed through data analysis.This is a clinical issue.The sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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