PERMCATH

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, BLUNT DISSECTION WAS DONE TO REMOVE THE CATHETER'S CUFF BUT IT WAS UNSUCCESSFUL AFTER MULTIPLE ATTEMPTS. THE CATHETER WAS SAID TO BE VERY FLOPPY AND DIFFICULT TO REMOVE. THE DISTAL END OF THE CATHETER WAS INADVERTENTLY SEVERED AND THE PROXIMAL END OF THE CATHETER WAS CLAMPED WITH A HEMOSTAT. IT WAS SAID THAT THE PATIENT WAS THEN TRANSFERRED TO THE INTERVENTIONAL RADIOLOGY LABORATORY AND THE PATIENT'S NECK AND CHEST WAS THEN RE-PREPPED IN STERILE FASHION. FLUOROSCOPIC IMAGING REVEALED A SHEARED THOUGH INTACT TUNNELED DIALYSIS CATHETER. NEXT, SMALL INCISION WAS MADE SUPERIOR TO THE INSERTION SITE AND BY USING A SHARP AND BLUNT DISSECTION, THE CATHETER WAS FREED AND SUBSEQUENTLY REMOVED. MANUAL PRESSURE WAS HELD OVER THE RIGHT INTERNAL JUGULAR VEIN AREA UNTIL HEMOSTASIS WAS ACHIEVED. THE SMALL INCISION WAS CLOSED WITH 3-0 VICRYL SUTURE. THE PATIENT LEFT THE INTERVENTIONAL RADIOLOGY LABORATORY IN STABLE CONDITION.