SPROTTE®

Description of Event or Problem

IRN# (B)(4) THIS INCIDENT TOOK PLACE IN FRANCE. THE DEPARTMENT REPORTED AN INITIAL FAILURE OF THE LUMBAR PUNCTURE PROCEDURE USING A STANDARD INTRODUCER. THE LUMBAR. PUNCTURE WAS SUBSEQUENTLY PERFORMED USING A LONG ATRAUMATIC NEEDLE. DURING NEEDLE ADVANCEMENT, BONY CONTACT. OCCURRED. UPON WITHDRAWAL, THE NEEDLE FRACTURED AT ITS MIDPOINT, LEAVING A FRAGMENT IN SITU. THE PATIENT WAS TRANSFERRED TO THE NEURORADIOLOGY DEPARTMENT, WHERE AN INCISION WAS MADE TO REMOVE THE NEEDLE FRAGMENT UNDER FLUOROSCOPIC GUIDANCE. THE LUMBAR PUNCTURE WAS THEN SUCCESSFULLY COMPLETED UNDER FLUOROSCOPIC GUIDANCE. PAIN AT THE PUNCTURE SITE WAS REPORTED FOLLOWING THE PROCEDURE AND WAS RELIEVED BY THE ADMINISTRATION OF 1 G OF PARACETAMOL. NO OTHER COMPLICATIONS HAVE BEEN OBSERVED TO DATE. THE BROKEN NEEDLE FRAGMENT WAS SUCCESSFULLY REMOVED UNDER FLUOROSCOPIC GUIDANCE.

Additional Manufacturer Narrative

IRN# (B)(4) THIS INCIDENT TOOK PLACE IN FRANCE. INVESTIGATIONS ARE ONGOING. FINAL EVALUATION IS BEING TRANSMITTED IN FINAL REPORT.