Product event summary: the device and data files were returned and analyzed.Data files showed that at 2 applications were performed with a balloon catheter with no issues.Also, data files showed 10 applications were performed with another balloon catheter with a system notice indicating that the refrigerant delivery path was obstructed (# (b)(4)) during an application.Visual inspection showed that the catheter was intact with no apparent issue.Smart chip verification showed that the catheter was used two injections.A performance test did not show any system notices.The catheter passed the deflection test as per specification.A dissection showed a guide wire lumen kink 0.97 inches from the tip of the catheter.The catheter failed the performance test due to a kink on guide wire lumen.If information is provided in the future, a supplemental report will be issued.
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It was reported that prior to a cryo ablation procedure, it was observed that the balloon catheter shaft was bent.The balloon catheter was then replaced, and the procedure continued.During initial ablation, a system notice was received indicating that the refrigerant delivery path was obstructed.The case was completed with cryo.No patient complications have been reported as a result of this event.The device was returned to the manufacturer, analyzed, and tested out of specification.
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