SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Description of Event or Problem

AS REPORTED, BEFORE USE IN PATIENT, A SWAN-GANZ PACING CATHETER WAS FOUND TO HAVE FIBER-LIKE MATERIAL PROTRUDING FROM THE CATHETER TIP. THEREFORE, THIS CATHETER WAS NOT USED FOR THE PATIENT. IT IS UNCLEAR WHETHER A NEW CATHETER WAS USED FOR THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.