BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER

Additional Manufacturer Narrative

(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 THE BARD MEDICAL TEMPORARY PACING ELECTRODE CATHETER REF 006173P, LOT GFJU1609. THE CATHETER COULD NOT BE INSERTED DOWN TWO DIFFERENT INTRODUCER SETS AND CHECKED THE INTRODUCER WITH A FRESH CATHETER WHICH PASSES WITHOUT ISSUE, SO WE BELIEVE THE ISSUE TO BE WITH THE PACING ELECTRODE CATHETER.