RLSND121-1.5

Description of Event or Problem

DURING A CARTOID ENDARTERECTOMY (CEA) A SUBDERMAL NEEDLE ELECTRODE (13MM NEEDLE) DISLODGED IN POSTERIOR RIGHT CALF. THE USER NOTED THAT THE NEEDLE WAS REMOVED BY FIRST REMOVING THE TAPE COVERING THE NEEDLE, FOLLOWED WITH REMOVAL OF THE NEEDLE FROM THE PATIENT. THE USER NOTED THAT THE NEEDLE TIP WAS DETACHED FROM THE ELECTRODE AND REMAINED IN THE PATIENT. A SMALL SKIN INCISION WAS MADE AFTER CLEANSING THE SKIN WITH BETADINE. LIMITED WOUND EXPLORATION AND ULTRASOUND COULD NOT LOCALIZE THE NEEDLE TO REMOVE IT. TWO SKIN CLOSURE STITCHES WITH 4-0 MONOCRYL WERE PLACED AND DERMABOND WAS APPLIED. AN XRAY WAS PERFORMED. THE DECISION WAS MADE TO LEAVE THE NEEDLE IN THE PATIENT UNTIL A FUTURE SURGERY IS PERFORMED TO ADDRESS THIS FOREIGN BODY AT A FOLLOW-UP APPOINTMENT IF THE NEEDLE TIP IS CAUSING DISCOMFORT OR PAIN. THE USER NOTED SOME POTENTIAL CONCERN FOR ELECTRODE CONTINUITY DURING STIMULATION, AND NOTED THERE WAS SOME CURRENT RETURN ISSUES IN THE RIGHT LEG DURING THE CASE WHEN PARALYTIC HAD WORN OFF AND PATIENT WAS MOVING LEGS WITH STIMULATION. WHEN ANESTHESIA HAD REDOSED PARALYTIC, THE CURRENT RETURN RECOVERED, AND THE STIMULATION APPEARED TO BE WORKING AS NORMAL THROUGHOUT REMAINDER OF THE PROCEDURE.

Additional Manufacturer Narrative

THE FULL DEVICE WAS NOT RETURNED FOR EVALUATION, THE SAMPLE CONSISTED OF A PARALLEL PAIR LEADWIRE WITH ONE INTACT ELECTRODE AND THE LEADWIRE JUNCTION WHERE THE COMPLAINT ELECTRODE HAD DETACHED. THE COMPLAINT SAMPLE INVESTIGATION WAS PERFORMED AND IDENTIFIED THAT THE NEEDLE ELECTRODE APPEARED TO BE BROKEN RATHER THAN DETACHED FROM THE LEADWIRE; A SMALL PORTION OF THE NEEDLE WAS STILL ATTACHED TO THE LEADWIRE.