SPROTTE®

Description of Event or Problem

IRN# (B)(4). ORIGINAL TEXT (FRANCE): LE (B)(6) 2024 MATIN, L'ANESTHÉSISTE RÉALISE UNE RACHI ANESTHÉSIE CHEZ UNE PATIENTE QUI A DÉJÀ EU UNE CHIRURGIE DU RACHIS (SANS POSE DE MATÉRIEL). LORS DE LA RÉALISATION DE LA RACHI ANESTHÉSIE SENSATION DE TISSU SOUS CUTANÉE DUR ET RIPPANT LORS DE L'AVANCÉ DE L'AIGUILLE PROBABLEMENT EN RAPPORT AVEC LA FIBROSE POST OPÉRATION. SENSATION DE DURETÉ IMPORTANTE AU BOUT DE L'AIGUILLE DE L'ANESTHÉSISTE EN RAPPORT AVEC UN CONTACT OSSEUX. RETRAIT DE L'AIGUILLE POUR RÉORIENTATION. CONSTATATION QU'IL MANQUE UNE PARTIE IMPORTANTE DE L'AIGUILLE, LE MÉDECIN EN DÉDUIT DONC QUE LE RESTE EST À L'INTÉRIEUR DE LA PATIENTE. ANNULATION DE L'OPÉRATION ET REPORT AFIN DE LA PRENDRE EN CHARGE ET RETIRER SOUS SCANNER CE CORPS ÉTRANGER. LORS DU SCANNER DIAGNOSTIQUE : BOUT DE L'AIGUILLE EN CONTACT AVEC LE PROCESSUS TRANSVERSE GAUCHE DE L5 ET L'AUTRE EXTRÉMITÉ DANS LE TISSU ADIPEUX À 4 CM SOUS LA SURFACE DE LA PEAU. SUCCÈS DE L'INTERVENTION DU RADIOLOGUE QUI A RÉALISÉ L'ABLATION DE L'AIGUILLE SOUS ANESTHÉSIE LOCALE GUIDÉE PAR SCANNER. TRANSLATION TEXT (ENGLISH): ON THE MORNING OF (B)(6) 2024, THE ANAESTHETIST PERFORMED A RACHI ANAESTHESIA ON A PATIENT WHO HAD ALREADY UNDERGONE SPINAL SURGERY (WITHOUT THE USE OF EQUIPMENT). WHEN PERFORMING THE RACHI ANESTHESIA, THE PATIENT EXPERIENCED A SENSATION OF HARD SUBCUTANEOUS TISSUE THAT RIPPLED WHEN THE NEEDLE WAS ADVANCED, PROBABLY DUE TO POSTOPERATIVE FIBROSIS. SENSATION OF SIGNIFICANT HARDNESS AT THE TIP OF THE ANAESTHETIST'S NEEDLE, RELATED TO BONE CONTACT. NEEDLE WITHDRAWN FOR REORIENTATION. A LARGE PART OF THE NEEDLE IS FOUND TO BE MISSING, SO THE DOCTOR DEDUCES THAT THE REST IS INSIDE THE PATIENT. THE OPERATION WAS CANCELLED AND POSTPONED SO THAT THE FOREIGN BODY COULD BE REMOVED UNDER SCAN. ON DIAGNOSTIC SCAN: TIP OF NEEDLE IN CONTACT WITH LEFT TRANSVERSE PROCESS OF L5 AND OTHER END IN ADIPOSE TISSUE 4 CM BELOW SKIN SURFACE. SUCCESSFUL INTERVENTION BY THE RADIOLOGIST, WHO REMOVED THE NEEDLE UNDER CT-GUIDED LOCAL ANAESTHETIC.

Additional Manufacturer Narrative

EVENT TOOK PLACE IN FRANCE. BASED ON ANALYSIS, RISK ASSESSMENT, RISK PROFILE AND CLINICAL MONITORING THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY. THIS IS AN INITAL AND FU1 REPORT - COMBINED. THIS PRODUCT ANALYSIS WAS CARRIED OUT ON THE BASIS OF ALL THE INFORMATION PROVIDED AND THE INTERNAL REVIEW AT PAJUNK. BASED ON ANALYSIS, RISK ASSESSMENT, RISK PROFILE AND CLINICAL MONITORINGTHIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.