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 02/05/2018 |
Event Type
malfunction
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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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Event Description
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It was reported that during a cryo ablation procedure, a guide wire lumen kink inside the balloon was visible on fluoroscopy.The balloon was deflated and re-inflated without resolve.The balloon catheter was replaced with resolve, 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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Product event summary: the device was returned and analyzed.Visual inspection of the catheter showed that the device was intact with no apparent issues.Smart chip verification indicated that the catheter was used for 3 injections.No system notice triggered during functional testing.A dissection showed a guide wire lumen kink 1.46 inches from the catheter tip.Pressure testing did not show any leaks.In conclusion, the reported kink issue was confirmed through testing.The catheter failed the return inspection due to a guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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