SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW HAS NOT BEEN 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.

Description of Event or Problem

AS REPORTED DURING USE AFTER INSERTING THE CATHETER FROM THE SUBCLAVIAN VEIN TO CARDIAC APEX THROUGH THE INTRODUCER, THIS SWAN-GANZ PACING CATHETER DID NOT PACE OR SENSE FROM THE BEGINNING OF USE. A NEW CATHETER WITH A DIFFERENT LOT NUMBER WAS INSERTED TO THE PATIENT. HOWEVER, THE PACING/SENSING ISSUE WAS OBSERVED AGAIN WITH THIS 2ND CATHETER. THEREFORE, A 3RD CATHETER WAS INSERTED AND THE ISSUE WAS RESOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.