BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER

Additional Manufacturer Narrative

INITIAL REPORTER PHONE NUMBER: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, A TEMPORARY PACEMAKER ELECTRODE DEVICE WAS OPENED; HOWEVER, UPON VERIFYING THE INFLATION OF THE DEVICE'S BALLOON, IT FAILED TO FUNCTION. THIS RENDERED THE PLACEMENT AND FIXATION OF THE DEVICE IMPOSSIBLE AND INEFFECTIVE. A SECOND, SEALED ELECTRODE WAS ATTEMPTED, BUT THE SAME MISHAP OCCURRED: IT WAS FOUND TO BE COLLAPSED AND WOULD NOT INFLATE. IT RESULTED IN OR PROLONGED HOSPITALIZATION. THE PRODUCTS HAVE ALREADY BEEN DISCARDED AND THEREFORE NOT AVAILABLE FOR RETURN.