Initial reporter phone: (b)(6).Intellanav st catheter was evaluated by boston scientific corporation.Visual inspection noted that the device presents a twist in the distal part of the catheter shaft and is broken in the proximal part of the catheter shaft.A functional test was performed, and the test shows that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.Finally, a dimensional test was done, and the device did not meet one of the curves reached.Laboratory analysis was able to confirm the reported clinical observations.
|
Reportable based on analysis completed on 05jan2023.It was reporter that during procedure to treat paroxysmal supraventricular tachycardia in the tricuspid annulus, an intellanav st catheter was selected for use.Durring the procedure the catheter was deformed.The catheter was replaced, and the issue was resolved.Procedure was able to be completed successfully without any complications.Catheter was returned to boston scientific corporation for laboratory analysis.Product investigation revealed a break in the proximal part of the catheter shaft.
|