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 01/24/2017 |
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, after the balloon catheter was inserted into the sheath, air was removed.However, air remained in the sheath.The sheath was replaced to resolve the issue and 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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Data files were returned and analyzed.Data files showed did not confirm any issues with the sheath.In conclusion, the reported issue could not be confirmed through data files.Device investigation still in progress.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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Manufacturer Narrative
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Event summary: upon visual inspection of the sheath 4fc12 / lot # 13788-059, results showed the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.In conclusion, the reported issue has been confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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