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 03/07/2017 |
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 cryoablation procedure, air ingress was observed during aspiration.The balloon catheter was reinserted into the sheath without resolution.The balloon catheter was replaced as the physician was concerned that the shaft might have been deformed.The replacement balloon catheter was inserted into the sheath and air ingress was continued to be observed.The sheath was then replaced with temporary resolution.When aspiration was performed in the latter half of the procedure, however, a small amount of air was observed.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 for the date of the event were returned and analyzed.The data files showed eight injections performed with balloon catheter, 2af284 lot 83206, without issue.The reported air ingress cannot be confirmed through data analysis; results are pending investigation of the returned physical product.
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Manufacturer Narrative
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Product event summary: the sheath was returned and analyzed.Visual inspection of the sheath 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; the valve was torn.The reported issue (air ingress) has been confirmed through testing.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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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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