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Model Number 4FC12 |
Device Problems
Gas/Air Leak (2946); Material Twisted/Bent (2981)
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Patient Problem
Air Embolism (1697)
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Event Date 10/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product event summary: the 4fc12 sheath with lot number: 0009952792 and the data files were returned and analyzed.The data files did not record any failure on the reported date of the event.The reported air ingress could not be assessed through data analysis.Visual inspection of the sheath showed the shaft was kinked in the middle and the side tube and the sheath was full of blood.The blood was flushed out.The reported air ingress could not be reproduced.Performance testing with a sentinel blackbelt leak tester revealed the pressure decay was within the expected range.The shaft and valve were leak tight with no apparent issue.The flush and air aspiration/ingress issues were not reproduced.The sheath was aspirated upon inserting the balloon catheter.The aspiration and flushing was done when the balloon was in the sheath and also when the balloon was out of the sheath past the radiopaque markers.No air bubble was observed.There was no blockage along the shaft, and the shaft and side port were leak tight.Insertion and retraction tests were performed without any friction.In conclusion, the reported air ingress was not confirmed through testing.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician, and is the adverse event being reported, along with air embolism.The sheath failed the returned product analysis due to the shaft kink.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, when the balloon catheter was inserted, a 'large image' was noted on the x-ray and was suspected to be an air bubble.The case was aborted with the patient under general anesthesia.Small air bubbles were also noted during the system flush, as a pump was used.It was unknown whether the vacuum had been enabled.The patient was hospitalized for overnight monitoring, but no clinical issues were noted, and their current status was 'alive - no injury.' no further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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