EPISPIN NRFIT

Additional Manufacturer Narrative

(B)(4). THIS INCIDENT TOOK PLACE IN UK (SCOTLAND). THE DEVICE SUBJECT TO THE CLAIM HAS BEEN REQUESTED FOR ANALYSIS. INVESTIGATIONS ARE ONGOING. FINAL EVALUATION IS BEING TRANSMITTED IN FINAL REPORT.

Description of Event or Problem

(B)(4) THIS INCIDENT TOOK PLACE IN UK (SCOTLAND) FIRST USED AN 80 MM CSE KIT AND WAS UNSUCCESSFUL, SO THEN USED A 135MM CSE KIT. UPON INSERTION OF THE SPINAL NEEDLE, MINIMAL CSF & SOME BLOOD WERE NOTICED, SO DECIDED A SECOND LONG-LENGTH CSE KIT WAS REQUIRED. SPINAL NEEDLE WAS REMOVED BUT KEPT THE EPIDURAL NEEDLE IN SITU. ONLY THE SPINAL NEEDLE OF THE SECOND CSE KIT WAS USED, LOR WAS CHECKED PRIOR TO INSERTION OF SECOND SPINAL NEEDLE, CSF WAS NOTICED, SO INJECTED DOWN THE SPINAL NEEDLE WITH NO RESISTANCE. THE SPINAL NEEDLE WAS REMOVED & EPIDURAL CATHETER WAS PLACED. THE CATHETER COULD ONLY BE THREADED 3CM WITH SOME DIFFICULTY; THE BLOCK WAS FELT NOT TO BE SUCCESSFUL POST-INJECTION DOWN THE EPIDURAL CATHETER, SO IT WAS REMOVED, & DECIDED TO PERFORM A STANDARD SPINAL WAS PERFORMED, WHICH WAS SUCCESSFUL. PATIENT LEFT WITH SOME BACK PAIN AND HEADACHE. DAY 9, THE PATIENT RETURNED WITH ONGOING BACK PAIN & HEADACHE. THEY TESTED FOR PDPH BUT SAW NO ISSUE AND DID NOT MEET CLINICAL CRITERIA FOR SCANNING. DAY 12, THE PATIENT RETURNED WITH CONTINUED HEADACHES & BACK PAIN. SCANNED FOR LOW CSF & CT SCAN OF THE SPINE, WHERE A SPINAL NEEDLE FRAGMENT WAS FOUND. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE A 9.5 CM FRAGMENT FROM THE PATIENT.