It was reported that right ventricular perforation occurred when the catheter was inserted during a tavi procedure.The customer noticed decreased blood pressure and fluoroscopy revealed cardiac tamponade.Pericardiocentesis was performed.The customer was suspicious that the adverse events were attributable to the catheter because the catheter tip felt stiffer than usual.The catheter was discarded.Patient demographic information, outcome, and status was requested but is unknown, further information could not be obtained as reporter declined to be interviewed.
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The device was not returned for evaluation.Without the return of the device it is not possible to assess any manufacturing issues with the device.The lot number was not provided thus a device history record was not reviewed.The instructions for use , under complications perforation of the right ventricle states as follows, cases of myocardial perforation associated with the use of temporary transvenous pacing catheters have been reported.Careful repositioning and withdrawal of the catheter under ecg and fluoroscopic control is recommended.The instructions for use has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions or conditions for the successful use of the device.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of this monthly review.No corrective or preventative actions are required at this time.
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