SPROTTE® 2.G

Description of Event or Problem

IRN# (B)(4). THIS INCIDENT TOOK PLACE IN FRANCE. 23-YEAR-OLD PATIENT HOSPITALIZED FOR INVESTIGATION OF INTRACRANIAL HYPERTENSION. AN ATTEMPT AT LUMBAR PUNCTURE WAS MADE ON (B)(6) 2026 WITH PREMEDICATION USING 20 MG OF SERESTA AND APPLICATION OF AN EMLA PATCH APPROXIMATELY 30 MINUTES BEFORE THE PROCEDURE. SKIN PREPARATION WAS PERFORMED WITH SOAP FOLLOWED BY CHLORHEXIDINE. A 24G VIOLET NEEDLE WAS USED. DESPITE A PROPERLY CONDUCTED PROCEDURE, IT WAS IMPOSSIBLE TO REACH THE VERTEBRAE (BMI: 39.96). THE NEEDLE WAS INSERTED ALMOST UP TO THE HUB, AND WITHDRAWAL OF THE STYLET PROVED DIFFICULT; IT WAS EVENTUALLY REMOVED, TWISTED AT ITS TIP. REMOVAL OF THE NEEDLE SHOWED THAT IT WAS SPLIT IN ITS DISTAL THIRD. A LUMBAR SPINE X-RAY WAS PERFORMED, CONFIRMING THAT A 6.62 MM FRAGMENT OF THE NEEDLE REMAINED AT THE LEVEL OF THE L4-L5 INTERSPINOUS SPACE. REMOVAL OF THE NEEDLE FRAGMENT WAS CARRIED OUT UNDER GENERAL ANESTHESIA BY A NEUROSURGEON ON (B)(6) 2026.

Additional Manufacturer Narrative

IRN# (B)(4). THIS INCIDENT TOOK PLACE IN FRANCE. THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SEND TO THE AGENCY.