Product event summary: the balloon catheter, 2af283 with lot number 30348 was returned and analyzed.Visual inspection of the device showed the device had a kinked guide wire lumen.Smart chip verification indicated the catheter was used for four applications.The catheter passed the functional test.Dissection showed a guide wire lumen kink at 1.08 inches from the tip inside the balloons.Furthermore, pressure test did not show any leaks.In conclusion, the kink was confirmed through testing.The balloon catheter failed the inspection due to the 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, the balloon was observed to be bent when the catheter was introduced into the sheath.The balloon catheter was replaced, and the case was completed with cryo.No patient complications have been reported as a result of this event.The balloon catheter subsequently tested out of specification per the manufacturer's investigation.
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