ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING THE INSERTION OF A CHRONIC HEMODIALYSIS CATHETER (CHDC), WHEN ATTEMPTING TO INSERT THE PEEL-AWAY SHEATH AND DILATOR INTO THE VESSEL, THE SHEATH PREMATURELY SPLIT LONGITUDINALLY. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY INDICATED THAT PRIOR TO DILATION, AN APPROXIMATELY 1 CM SKIN INCISION WAS MADE OVER THE SPRING WIRE GUIDE (SWG), AND BLUNT DISSECTION WAS PERFORMED USING CLAMPS TO FACILITATE TUNNELING OF THE CHDC. THE DILATORS AND PEEL-AWAY SHEATH WERE ADVANCED IN THE USUAL MANNER USING A GENTLE TWISTING MOTION. HOWEVER, IN THIS CASE, THE PEEL-AWAY SHEATH SPLIT IMMEDIATELY UPON ATTEMPTED INSERTION, PREVENTING ADVANCEMENT OR INITIATION OF THE TWISTING MOTION. THE AFFECTED DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT DEVICE. THE EVENT RESULTED IN AN APPROXIMATE 10-15 MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT OTHER THAN THE PROCEDURAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THAT DESCRIBED.