ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE

Additional Manufacturer Narrative

INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Description of Event or Problem

SONTHALIA ET AL. ¿ 2023 ¿ ENDOSCOPIC ULTRASOUND-GUIDED CELIAC PLEXUS BLOCK CAN BE A USEFUL PROCEDURE FOR PAIN RELIEF IN CHRONIC PANCREATITIS WHEN USED SELECTIVELY. BASELINE COAGULATION PROFILE WAS DONE FOR ALL THE PATIENTS BEFORE PROCEDURE. PREPROCEDURE 500ML OF BOLUS INTRAVENOUS NORMAL SALINE OVER 1 HOUR WAS GIVEN AND IT WAS CONTINUED AT 100ML/H DURING AND FOR 6 HOURS POSTPROCEDURE. IN ADDITION, 1 GM OF INTRAVENOUS CEFTRIAXONE WAS GIVEN TO ALL PATIENTS BEFORE THE PROCEDURE. ALL CASES WERE DONE UNDER PROPOFOL SEDATION WITH CONTINUOUS VITALS MONITORING. LINEAR ECHOENDOSCOPE FROM OLYMPUS (GF-UCT180) WITH ULTRASOUND PROCESSOR (EU-ME2 SYSTEM) WAS USED IN ALL CASES. AT FIRST, A DETAILED EVALUATION OF PANCREATIC ANATOMY AND PD STATUS WAS DONE. THEN THE ORIGIN OF CELIAC TRUNK FROM AORTA WAS IDENTIFIED FROM GASTROESOPHAGEAL JUNCTION/PROXIMAL GASTRIC BODY. LEFT ADRENAL WAS THEN IDENTIFIED BY TORQUING CLOCKWISE FROM CELIAC TRUNK. CELIAC PLEXUS WAS IDENTIFIED IN THE SPACE BETWEEN CELIAC TRUNK AND LEFT ADRENAL. DISTANCE BETWEEN THE PROBE AND 2MM ABOVE CELIAC TAKE-OFF WAS MEASURED AND AN AVASCULAR PATH WAS IDENTIFIED. NEEDLE USED WERE EITHER 20G EUS-CPN NEEDLE FROM ((ECHO-20-CPN; COOK MEDICAL) OR 22G FINE-NEEDLE ASPIRATION NEEDLE (EXPECT; BOSTON SCIENTIFIC, NATICK, MASSACHUSETTS, UNITED STATES). STYLET WAS REMOVED AND NEEDLE WAS PRIMED WITH NORMAL SALINE BEFORE PUNCTURE. NEEDLE WAS PUNCTURED AND ADVANCED TILL JUST 2MM ANTERIOR TO CELIAC TRUNK. AFTER NEEDLE PUNCTURE, 2ML STERILE SALINE WAS INJECTED TO CONFIRM POSITION THEN SUCTION WAS APPLIED FOR 10 SECONDS TO THE SYRINGE TO LOOK FOR ANY BLOOD RETURN. THEN FEW MILLILITERS OF SALINE FLUSH WERE USED TO CLEAR NEEDLE OF ANY GASTRIC WALL CONTAMINANT. ONCE THE NEEDLE WAS IN POSITION, 20ML OF 0.25% BUPIVACAINE WAS INJECTED FOLLOWED BY INJECTION OF 40MG OF TRIAMCINOLONE ACETATE IN ALIQUOTS OF 5ML IN ALL CASES. ADDITIONAL 40MG OF TRIAMCINOLONE ACETATE WAS INJECTED IN SOME CASES WHERE IT WAS FEASIBLE AS PER ENDOSONOGRAPHERS PREFERENCE. CENTRAL INJECTION TECHNIQUE WAS USED IN ALL CASES WHERE INJECTION WAS DONE EITHER JUST ANTERIOR OR SLIGHT LEFT LATERAL TO CELIAC TRUNK. WHEREVER IDENTIFIED, INTRAGANGLION INJECTION WAS ALSO DONE IN ADDITION TO CENTRAL INJECTION WHERE ADDITIONAL 20MG (2.5ML) OF TRIAMCINOLONE ACETATE WAS INJECTED IN THE GANGLIONS (ONLY 5 CASES). TWO MILLILITER OF SALINE FLUSH THROUGH THE NEEDLE WAS GIVEN BEFORE WITHDRAWAL TO CLEAR NEEDLE AND AVOID SPILLAGE. POST PROCEDURE INTRAVENOUS HYDRATION AND CONTINUOUS VITAL MONITORING TO LOOK FOR ANY HYPOTENSION WAS DONE. PATIENTS WERE DISCHARGED EITHER ON SAME DAY OR NEXT DAY WITH A COURSE OF ORAL ANTIBIOTICS FOR 5 DAYS. OTHER MEDICAL TREATMENT FOR CHRONIC PANCREATITIS WAS CONTINUED AS BEFORE. PATIENTS WERE ADVISED TO USE ANALGESICS ONLY IF PAIN WAS SEVERE ON EMERGENCY BASIS ON FOLLOW-UP. FOLLOW-UP WAS DONE DURING FOLLOW-UP CLINIC VISITS OR OVER TELEPHONIC INTERVIEW IN SOME CASES. THIS FILE WILL CAPTURE ONE OCCURRENCE OF MILD BLEEDING -INHERENT RISK OF THE NEEDLE PUNCTURE. THE PATIENT WAS MANAGED CONSERVATIVELY.

Additional Manufacturer Narrative

DEVICE EVALUATION: THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, ENDOSCOPIC ULTRASOUND-GUIDED CELIAC PLEXUS BLOCK CAN BE A USEFUL PROCEDURE FOR PAIN RELIEF IN CHRONIC PANCREATITIS WHEN USED SELECTIVELY". THIS FILE CAPTURES 1 PATIENT WHO EXPERIENCED MINOR BLEEDING. THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINTS FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO (B)(4). MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, THE DEVICES WERE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: AS PER THE INSTRUCTIONS FOR USE, IFU0039 WHICH INFORMS THE USER ABOUT THE INTENDED USE ¿THIS DEVICE IS USED TO DELIVER NEUROLYSING AGENTS TO THE CELIAC PLEXUS UNDER GUIDANCE BY ENDOSCOPIC ULTRASOUND.¿ AND CONTRAINDICATIONS ¿CONTRAINDICATIONS INCLUDE THOSE SPECIFIC TO THE PRIMARY ENDOSCOPIC PROCEDURE TO BE PERFORMED IN GAINING ACCESS TO THE DESIRED INJECTION SITE. CONTRAINDICATIONS TO CELIAC PLEXUS NEUROLYSIS INCLUDE, BUT ARE NOT LIMITED TO: COAGULOPATHY, USE OF ANTICOAGULANTS, ASPIRIN OR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS).¿ THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU0039), WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE FOLLOWING TO USER: "DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE.¿. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE USER IS ADVISED OF THE FOLLOWING POTENTIAL COMPLICATIONS IN THE IFU, (IFU0039): POTENTIAL ADVERSE EVENTS ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY AND CELIAC PLEXUS NEUROLYSIS INCLUDE, BUT ARE NOT LIMITED TO: AIRWAY OBSTRUCTION, ALLERGIC REACTION TO MEDICATION, ALLERGIC REACTION TO NICKEL, ASPIRATION, CARDIAC ARRHYTHMIA OR ARREST, DISCOMFORT, FEVER, GASTROPARESIS, HEMORRHAGE, HYPOTENSION, INFECTION, INFLAMMATION, LOWER EXTREMITY WEAKNESS, NAUSEA, PARAPLEGIA, PARESTHESIAS, PERFORATION, RENAL PUNCTURE, RESPIRATORY DEPRESSION OR ARREST, SEPSIS, TRANSIENT DIARRHEA, TRANSIENT INCREASING PAIN, VOMITING. THESE ARE KNOWN POTENTIAL ADVERSE EVENTS AS DESCRIBED IN THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE, INDICATIONS FOR USE OR CONTRAINDICATIONS OF THE DEVICE. FROM THE INFORMATION AVAILABLE, ECHO-20-CPN WAS USED OFF-LABEL DUE TO CELIAC PLEXUS BLOCKING AGENT. AS PREVIOUSLY MENTIONED, THE PRECAUTIONS SECTION OF THE IFU (IFU0039) STATES " DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE.¿. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE SECTION OF THE DEVICE. AS PER IFU POTENTIAL ADVERSE EVENTS ¿BLEEDING¿ IS A KNOWN POTENTIAL COMPLICATION. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. CONFIRMATION OF COMPLAINT COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY: CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. THIS FILE CAPTURES MINOR BLEEDING DUE TO NEEDLE PUNCTURE FOR 1 OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MINOR BLEEDING REQUIRED CONSERVATIVE MANAGEMENT. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS DETERMINED FROM THE AVAILABLE INFORMATION.

Description of Event or Problem

SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 31 JUL 2025.