Event summary: the patient data files showed at least two applications were performed with catheter 2af284 / 88584-(b)(4) without any system notices on the date of event.Both applications were performed without inflation.The data files showed at least six more applications were performed with catheter 2af284 / 88584-(b)(4) without any issues or system notices on the date of event.Upon visual inspection of catheter 2af284 / 88584-(b)(4), results showed that the catheter was intact with no apparent issue.Smart chip verification showed that the catheter has been used for two injections.Performance test did not show any system notice.Dissection showed that guide wire lumen kinked 1.27 inches from the tip of the catheter.The catheter failed the performance test due to kink on guide wire lumen.In conclusion, the reported issue has been confirmed through testing but not confirmed through the data analysis.The balloon 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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It was reported that during a cryo ablation procedure, upon insertion of the balloon catheter into the sheath, resistance was noted, but the catheter was able to be inserted.The balloon catheter was then inflated in the left atrium, and it was observed that the wire inside the balloon was bent.The catheter was replaced and the case was completed with cryo.No patient complications have been reported as a result of this event.
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