Model Number 2AF284 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Event summary: visual inspection of catheter 2af284/95149-62 showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for two injections.The catheter passed the functional test.No system notice was triggered during the functional test.Dissection showed a guide wire lumen kink at 1.40 inches from the tip inside the balloons.Pressure test did not show leaks.In conclusion, the reported system notice ((b)(4)) received indicating that the safety system detected blood in the catheter handle, the injection was stopped, and the vacuum disabled could not be confirmed through testing for returned product, but the catheter failed the inspection due to guide wire lumen 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, a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.The console was rebooted without resolve.The balloon catheter was then replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.On (b)(6) 2018: the device was returned to the manufacturer, analyzed, and tested out of specification.
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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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