Product event summary: the balloon catheter, 2af284 with lot number 21508 was returned and analyzed.Visual inspection of the balloon catheter showed the device was intact with no apparent issue.Smart chip verification showed that the catheter was used for 6 injections.Performance test did not show any system notice.The catheter passed the deflection test as per specification, and dissection did not show any problem in pull wire.Dissection showed that guide wire lumen kinked on 1.0720 inches from the tip of the catheter.The catheter failed the performance test due to kink on guide wire lumen.The steerability issue reported is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.If information is provided in the future, a supplemental report will be issued.
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