Event summary: the patient data files did not show system notices or issues for the date of event with catheter 2af284/98911-(b)(4) which was used for twelve injections.The data files did not show catheter 2af284/79078-(b)(4).Upon visual inspection of balloon catheter 2af284/79078-(b)(4), results showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for fourteen injections.Dissection showed a guide wire lumen kink at 1.4110 inches from the tip of the catheter.Pressure test did not show leaks.The catheter passed the performance test.In conclusion, the reported (balloon catheter kink and steerability) issue has not been confirmed through data analysis but through testing.The balloon catheter failed the 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 cryoablation procedure, the shaft inside the balloon was bent causing difficulty with maneuvering and vein occlusion.The balloon 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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