Model Number 4FC12 |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/29/2017 |
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, air was continually aspirated from the sheath and a valve leak was suspected.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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Event summary: the patient data files showed at least twelve applications were performed with catheter 2af284/73672-98 on the date of the event without any issues.Upon visual inspection of the flexcath sheath 4fc12 / 47539-066, results showed the sheath shaft was kinked twelve centimeters from the tip of the sheath.Air aspiration was reproduced when a catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.The valve was torn.In conclusion, the reported issue (air ingress during aspiration) was reproduced through the 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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