Event summary: upon visual inspection of balloon catheter 2af284 / 06615-42, results showed that the catheter was intact with no apparent issue.Smart chip verification showed that the catheter has been used for twelve injections.Performance test did not show any system notice.The catheter passed the deflection test as per specification.Dissection showed that guide wire lumen kinked on 1.3730 inches from the tip of the catheter.The catheter failed the performance test due to kink on guide wire lumen.In conclusion, the reported (guidewire lumen kink) issue has been confirmed through testing.The reported (steerability) issue has been not confirmed through testing and through the data analysis.The catheter failed the returned product inspection due to guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.
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It was reported that at the end of a cryo ablation procedure, the balloon was slightly malformed.It was then noted that the pull wire of the balloon catheter was exposed.The case was able to be completed with cryo.No patient complications have been reported as a result of this event.On 2018-04-25: upon return and analysis of the product, the catheter tested out of specification.
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