NON-RADIOPAQUE URODYNAMIC CATHETER WITH RADIOPAQUE MARK

Additional Manufacturer Narrative

ONE OPENED CATHETER WAS RECEIVED NOTING THE RADIOPAQUE MARKER BAND TO BE LOOSE INSIDE PACKAGE. THE CATHETER WAS MEASURED AND FROM THE DISTAL TIP OF THE MANIFOLD TO THE TIP WHERE THE SEPARATION OCCURRED MEASURED 37.4 CM; SPECIFIED LENGTH AT THE TIME OF MFR AS WELL AS CURRENT SPECIFICATIONS ARE 38CM +- 1CM. THE SEPARATION OCCURRED APPROX 1MM FROM THE FIRST SIDEPORT. THE SEPARATION HAD THE APPEARANCE OF BEING SMOOTH AND THEN TRANSITIONED INTO ROUGH EDGES; INDICATING IT WAS CUT AND THEN PULLED TO SEPARATION. THE CATHETER WAS NOTED TO HAVE ADEQUATE ADHESIVE AS WELL AS A GROVE IN THE CATHETER FROM WHERE THE RADIOPAQUE MARKER BAND HAD BEEN INDICATING PROPER ASSEMBLY OF MARKER AND CATHETER. UNABLE TO DETERMINE WHAT HAS CAUSED MARKER BAND TO COME OFF DURING PROCEDURE. SHOULD ADD'L INFO BECOME AVAILABLE, IT WILL BE FORWARDED.

Description of Event or Problem

CUSTOMER STATES: "THE TIP WAS CUT TO MAKE AN ENDHOLE, BUT NOT VERY CLOSE TO THE RADIOPAQUE MARKER AND THEN IT WAS INSERTED ON WIREGUIDE AND THEN INSERTED IN THE KIDNEY. PRESSURE MEASURING WITH JOSEPH URODYNAMIC CATHETER WAS MADE AND SHOWED PATHOLOGICAL VALUES DUE TO A STENOSIS IN THE PROXIMAL URETER, THEN WAS A DILATATION MADE WITH A BALLOON CATHETER 5F AND THEN WAS A PTC-CATHETER USED, 8F, BUT IT WAS NOT ABLE TO GO THROUGH DUE TO THE RADIOPAQUE MARKER WAS IN THE WAY (HAD LOOSENED FROM JOSEPH CATH) AND THE MARKER WAS LONG WAY DOWN IN THE URETER. THEN HE PUT IN A INTRODUCER TO THE URETER, 6F, AND THEN A BALLOON CATHETER TO PICK UP THE RADIOPAQUE MARKER AND THAT WAS SUCCESSFUL."