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 01/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary: the device and data files were returned and analyzed.Data files showed that 6 applications were performed with another catheter on the date of the event.Visual inspection of the catheter showed a kink on the guide wire lumen of the balloon.Also, a dissection showed a guide wire lumen kink 1.35 inches proximal from the tip.Smart chip verification indicated that the catheter was not used.The catheter passed the performance and electrical integrity test per specification.In conclusion, the reported catheter compatibility issue was confirmed through testing.The catheter failed the returned product 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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Event Description
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It was reported that during a cryo ablation procedure, the balloon catheter was unable to be inserted further in the sheath.The balloon catheter was replaced with resolve.The case was completed with cryo.The balloon catheter was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.
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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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