It was reported that during a cryo ablation procedure, the "inner sheath" of the balloon catheter was kinked.Additionally, difficulty was observed manipulating the balloon.The balloon catheter was replaced, and the same issue occurred.The case continued at the physician's discretion and was completed with cryo.No patient complications have been reported as a result of this event.
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Product event summary: the device and data files were returned and analyzed.Data files showed that 7 applications were performed with the catheter on the date of the event.A system notice indicating that the refrigerant delivery path was obstructed (#50012) was triggered on the first application.Visual inspection of the catheter showed no apparent issues.The catheter passed the deflection test as per specification.A dissection showed that the guide wire lumen kinked 1.41 inches from the catheter tip.The catheter failed the performance test due to a kink on guide wire lumen.In conclusion, the reported guide wire lumen kink was confirmed through testing but not confirmed through the data analysis.The catheters failed the return 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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