AUTOTOME - SPHINCTEROTOMES
Report
- Report Number
- 3005099803-2026-00603
- Event Type
- Death
- Date Received
- February 15, 2026
- Date of Event
- March 14, 2025
- Report Date
- May 7, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE ATTORNEY FOR THE PLAINTIFF (PATIENT). THE HEALTHCARE FACILITY IS: (B)(6) HOSPITAL. BLOCK H6: IMDRF PATIENT CODE E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF PATIENT CODE E1201 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E21104 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E1032 CAPTURES THE REPORTABLE EVENT OF VOMITING. IMDRF PATIENT CODE E1020 CAPTURES THE REPORTABLE EVENT OF NAUSEA. IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF PATIENT CODE E1001 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL DISTENTION. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED INFECTION. IMDRF PATIENT CODE E2327 CAPTURES THE REPORTABLE EVENT OF NECROSIS. IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF HYPOTENSION. IMDRF PATIENT CODE E060109 CAPTURES THE REPORTABLE EVENT OF TACHYCARDIA. IMDRF PATIENT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE EVENT OF PERITONITIS. IMDRF PATIENT CODE E010701 CAPTURES THE REPORTABLE EVENT OF CONFUSION/DISORIENTATION. IMDRF PATIENT CODE E0726 CAPTURES THE REPORTABLE EVENT OF HYPOXIA. IMDRF PATIENT CODE E0743 CAPTURES THE REPORTABLE EVENT OF RESPIRATORY INSUFFICIENCY. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED INJURY (THERMAL DAMAGE). IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F2306 CAPTURES THE REPORTABLE EVENT OF RESUSCITATION. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION.
BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE ATTORNEY FOR THE PLAINTIFF (PATIENT). THE HEALTHCARE FACILITY IS: (B)(6). BLOCK H2 (ADDITIONAL INFORMATION): BLOCK A2 (PATIENT DATE OF BIRTH), BLOCK B5 (DESCRIBE EVENT OR PROBLEM), BLOCK H6 (PATIENT CODES) HAVE BEEN UPDATED. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE/BLEEDING. IMDRF PATIENT CODE E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF PATIENT CODE E1201 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E21104 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E1032 CAPTURES THE REPORTABLE EVENT OF VOMITING. IMDRF PATIENT CODE E1020 CAPTURES THE REPORTABLE EVENT OF NAUSEA. IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF PATIENT CODE E1001 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL DISTENTION. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED INFECTION. IMDRF PATIENT CODE E2327 CAPTURES THE REPORTABLE EVENT OF NECROSIS. IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF HYPOTENSION. IMDRF PATIENT CODE E060109 CAPTURES THE REPORTABLE EVENT OF TACHYCARDIA. IMDRF PATIENT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE EVENT OF PERITONITIS. IMDRF PATIENT CODE E010701 CAPTURES THE REPORTABLE EVENT OF CONFUSION/DISORIENTATION. IMDRF PATIENT CODE E0726 CAPTURES THE REPORTABLE EVENT OF HYPOXIA. IMDRF PATIENT CODE E0743 CAPTURES THE REPORTABLE EVENT OF RESPIRATORY INSUFFICIENCY. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F2306 CAPTURES THE REPORTABLE EVENT OF RESUSCITATION. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVIE REQUIRED. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. BLOCK H11: INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS UNABLE TO BE PERFORMED AS THE UPN AND LOT NUMBER ARE UNKNOWN. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF HEMORRHAGE/BLEEDING, SHOCK, SEPTIC, PANCREATITIS, PERFORATION, PAIN, ABDOMINAL, VOMITING, NAUSEA, CARDIAC ARREST, ABDOMINAL DISTENTION, INFECTION, NECROSIS, HYPOTENSION, TACHYCARDIA, URINARY RETENTION, PERITONITIS, CONFUSION/DISORIENTATION, DEATH, UNEXPECTED MEDICAL INTERVENTION, HOSPITALIZATION OR PROLONGED HOSPITALIZATION, MEDICATION REQUIRED, RESUSCITATION, IMAGING REQUIRED, INTENSIVE CARE, ADDITIONAL DEVICE REQUIRED, SURGICAL INTERVENTION WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AT (B)(6) HOSPITAL. DURING THE ERCP, A CUTTING MALFUNCTION OCCURRED WITH THE AUTOTOME PRO RX SPHINCTEROTOME, PREVENTING COMPLETE SPHINCTEROTOMY. STENTS WERE PLACED IN BOTH THE PANCREATIC AND COMMON BILE DUCTS, AND A CELIAC PLEXUS BLOCK FOR PAIN MANAGEMENT. THE PROCEDURE DURATION WAS SEVEN MINUTES AND NINE SECONDS. IT WAS REPORTED THAT WERE NO IMMEDIATE COMPLICATIONS AT THE CONCLUSION OF THE PROCEDURE. POST-PROCEDURE, THE PATIENT DEVELOPED SEVERE ABDOMINAL PAIN, NAUSEA, AND VOMITING. SHE WAS ADMITTED TO (B)(6) HOSPITAL WITH A DIAGNOSIS OF POST-ERCP PANCREATITIS. A PHYSICIAN ASSESSMENT NOTED ACUTE ON CHRONIC PANCREATITIS SECONDARY TO PANCREATIC DIVISUM WITH SEPTIC SHOCK, HYPOTENSION, AND ELEVATED LACTIC ACID LEVELS. CT IMAGING REVEALED FREE AIR CONSISTENT WITH PERFORATION, PROMPTING AN EMERGENCY EXPLORATORY LAPAROTOMY AND TEMPORARY ABDOMINAL CLOSURE. THE PATIENT WAS THEN TRANSFERRED TO A SURGICAL INTENSIVE CARE UNIT (SICU) AT (B)(6). ON (B)(6) 2025, A GI CONSULT DIAGNOSED POST-ERCP PANCREATITIS, NAUSEA, VOMITING, AND PANCREAS DIVISUM. THE PATIENT'S PULSE WAS RECORDED AT 132 BPM, CONSISTENT WITH TACHYCARDIA. NURSING NOTES DOCUMENTED PERSISTENT ELEVATED HEART RATE, URINARY RETENTION, AND ADMINISTRATION OF IV FLUIDS AND METOPROLOL. A CRITICAL CARE CONSULT CITED RESPIRATORY DISTRESS, PNEUMOPERITONEUM, AND PNEUMORETROPERITONEUM. THE PATIENT WAS BEING TREATED WITH THREE VASOPRESSORS: LEVOPHED, PHENYLEPHRINE, AND VASOPRESSIN, ALONG WITH VANCOMYCIN, ZOSYN, AND STEROIDS. BLOOD CULTURES OBTAINED DURING THIS TIME GREW ACINETOBACTER BAUMANNII, A MULTIDRUG-RESISTANT HOSPITAL-ACQUIRED INFECTION. ON (B)(6), 2025, THE PATIENT REQUIRED VENTILATOR SUPPORT DUE TO RESPIRATORY COMPROMISE, AND IMAGING SHOWED FLUID IN HER ABDOMEN. PHYSICIANS PERFORMED ANOTHER EXPLORATORY LAPAROTOMY AND EGD TO ASSESS FOR A SUSPECTED BOWEL PERFORATION OR OTHER CAUSES OF ABDOMINAL FLUID ACCUMULATION. FINDINGS REVEALED BILE PERITONITIS BUT NO OBVIOUS PERFORATION. A DRAIN WAS PLACED NEAR THE DUODENUM AND PANCREAS. SHE REMAINED CRITICALLY ILL AND HEMODYNAMICALLY UNSTABLE. A PHYSICIAN CONSULT DESCRIBED THE PATIENT AS TOXIC-APPEARING, PALE, AND DISORIENTED, WITH ABDOMINAL DISTENTION, GUARDING, AND TACHYCARDIA. THE ASSESSMENT NOTED POST-ERCP PANCREATITIS COMPLICATED BY HYPOTENSION, SVT, AND HYPOXIA. SHE WAS TRANSFERRED TO THE (B)(6) FOR HIGHER LEVEL CARE IN THE. ICU ADMISSION NOTE DESCRIBED SEPTIC SHOCK LIKELY FROM BOWEL PERFORATION AFTER ERCP PANCREATITIS. A PHYSICIAN NOTED A DELAY IN ANTIBIOTIC ADMINISTRATION AND A SUSPICION OF THERMAL INJURY-INDUCED MICRO-PERFORATION CAUSED BY A DEVICE PROBLEM. ON (B)(6) 2025, AT 3AM, THE PATIENT'S CONDITION HAD WORSENED. SHE UNDERWENT ADDITIONAL SCOPES AND TESTING DUE TO CONCERNS ABOUT SEVERE INFECTION, LOW WHITE BLOOD CELL COUNT, AND A POTENTIAL "DEAD BOWEL." NO PERFORATION WAS FOUND DURING THESE PROCEDURES. THE PATIENT EXPERIENCED A PEA CARDIAC ARREST AND WAS RESUSCITATED AFTER TWO MINUTES OF CPR. SHE BRIEFLY REGAINED CIRCULATION. FOLLOWING RESUSCITATION, PHYSICIANS AGAIN PERFORMED A SCOPE BUT CONTINUED TO REPORT NO IDENTIFIABLE PERFORATION. HER TEMPORARY ABDOMINAL CLOSURE WAS REOPENED AT BEDSIDE, REVEALING GLOBALLY HYPOPERFUSED ORGANS BUT NO DEFINITIVE SOURCE OF SEPSIS. FOLLOWING CONTINUED INSTABILITY AND AFTER DISCUSSION WITH HER FAMILY, THE PATIENT'S CODE STATUS WAS CHANGED TO DO NOT RESUSCITATE (COMFORT CARE). SHE WAS PRONOUNCED DEAD AT 10:14AM. THE PATIENT'S DEATH CERTIFICATE LISTED CARDIAC ARREST, SEPTIC SHOCK, BILE DUCT INJURY, BILE DUCT STRICTURE, AND A PANCREATIC BILIARY PERFORATION, EVEN THOUGH NO PERFORATION HAD BEEN IDENTIFIED DURING THE MULTIPLE SCOPES PERFORMED WHILE SHE WAS ALIVE. THE AUTOPSY PERFORMED FOUND MULTIFOCAL NECROSIS OF THE PANCREATIC PARENCHYMA, FAT NECROSIS WITH SAPONIFICATION, AND ACUTE VASCULAR THROMBOSIS CONSISTENT WITH ACUTE NECROTIZING PANCREATITIS POST-ERCP. THE IMMEDIATE CAUSE OF DEATH WAS DETERMINED TO BE POST-ERCP ACUTE NECROTIZING PANCREATITIS COMPLICATED BY SEPSIS DUE TO DELAYED ANTIBIOTIC ADMINISTRATION, SURGICAL DEVICE MALFUNCTION, AND FAILURE TO IDENTIFY OR TREAT A PERFORATION.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AT (B)(6) HOSPITAL. DURING THE ERCP, A CUTTING MALFUNCTION OCCURRED WITH THE AUTOTOME PRO RX SPHINCTEROTOME, PREVENTING COMPLETE SPHINCTEROTOMY. STENTS WERE PLACED IN BOTH THE PANCREATIC AND COMMON BILE DUCTS, AND A CELIAC PLEXUS BLOCK FOR PAIN MANAGEMENT. THE PROCEDURE DURATION WAS SEVEN MINUTES AND NINE SECONDS. IT WAS REPORTED THAT WERE NO IMMEDIATE COMPLICATIONS AT THE CONCLUSION OF THE PROCEDURE. POST-PROCEDURE, THE PATIENT DEVELOPED SEVERE ABDOMINAL PAIN, NAUSEA, AND VOMITING. SHE WAS ADMITTED TO (B)(6) HOSPITAL WITH A DIAGNOSIS OF POST-ERCP PANCREATITIS. A PHYSICIAN ASSESSMENT NOTED ACUTE ON CHRONIC PANCREATITIS SECONDARY TO PANCREATIC DIVISUM WITH SEPTIC SHOCK, HYPOTENSION, AND ELEVATED LACTIC ACID LEVELS. CT IMAGING REVEALED FREE AIR CONSISTENT WITH PERFORATION, PROMPTING AN EMERGENCY EXPLORATORY LAPAROTOMY AND TEMPORARY ABDOMINAL CLOSURE. THE PATIENT WAS THEN TRANSFERRED TO A SURGICAL INTENSIVE CARE UNIT (SICU) AT (B)(6) MEDICAL CENTER. ON (B)(6) 2025, A GI CONSULT DIAGNOSED POST-ERCP PANCREATITIS, NAUSEA, VOMITING, AND PANCREAS DIVISUM. THE PATIENT'S PULSE WAS RECORDED AT 132 BPM, CONSISTENT WITH TACHYCARDIA. NURSING NOTES DOCUMENTED PERSISTENT ELEVATED HEART RATE, URINARY RETENTION, AND ADMINISTRATION OF IV FLUIDS AND METOPROLOL. A CRITICAL CARE CONSULT CITED RESPIRATORY DISTRESS, PNEUMOPERITONEUM, AND PNEUMORETROPERITONEUM. THE PATIENT WAS BEING TREATED WITH THREE VASOPRESSORS: LEVOPHED, PHENYLEPHRINE, AND VASOPRESSIN, ALONG WITH VANCOMYCIN, ZOSYN, AND STEROIDS. BLOOD CULTURES OBTAINED DURING THIS TIME GREW ACINETOBACTER BAUMANNII, A MULTIDRUG-RESISTANT HOSPITAL-ACQUIRED INFECTION. ON (B)(6) 2025, THE PATIENT REQUIRED VENTILATOR SUPPORT DUE TO RESPIRATORY COMPROMISE, AND IMAGING SHOWED FLUID IN HER ABDOMEN. PHYSICIANS PERFORMED ANOTHER EXPLORATORY LAPAROTOMY AND EGD TO ASSESS FOR A SUSPECTED BOWEL PERFORATION OR OTHER CAUSES OF ABDOMINAL FLUID ACCUMULATION. FINDINGS REVEALED BILE PERITONITIS BUT NO OBVIOUS PERFORATION. A DRAIN WAS PLACED NEAR THE DUODENUM AND PANCREAS. SHE REMAINED CRITICALLY ILL AND HEMODYNAMICALLY UNSTABLE. A PHYSICIAN CONSULT DESCRIBED THE PATIENT AS TOXIC-APPEARING, PALE, AND DISORIENTED, WITH ABDOMINAL DISTENTION, GUARDING, AND TACHYCARDIA. THE ASSESSMENT NOTED POST-ERCP PANCREATITIS COMPLICATED BY HYPOTENSION, SVT, AND HYPOXIA. SHE WAS TRANSFERRED TO THE (B)(6) MEDICAL CENTER ICU FOR HIGHER LEVEL CARE IN THE. ICU ADMISSION NOTE DESCRIBED SEPTIC SHOCK LIKELY FROM BOWEL PERFORATION AFTER ERCP PANCREATITIS. A PHYSICIAN NOTED A DELAY IN ANTIBIOTIC ADMINISTRATION AND A SUSPICION OF THERMAL INJURY-INDUCED MICRO-PERFORATION CAUSED BY A DEVICE PROBLEM. ON (B)(6) 2025, AT 3AM, THE PATIENT'S CONDITION HAD WORSENED. SHE UNDERWENT ADDITIONAL SCOPES AND TESTING DUE TO CONCERNS ABOUT SEVERE INFECTION, LOW WHITE BLOOD CELL COUNT, AND A POTENTIAL "DEAD BOWEL." NO PERFORATION WAS FOUND DURING THESE PROCEDURES. THE PATIENT EXPERIENCED A PEA CARDIAC ARREST AND WAS RESUSCITATED AFTER TWO MINUTES OF CPR. SHE BRIEFLY REGAINED CIRCULATION. FOLLOWING RESUSCITATION, PHYSICIANS AGAIN PERFORMED A SCOPE BUT CONTINUED TO REPORT NO IDENTIFIABLE PERFORATION. HER TEMPORARY ABDOMINAL CLOSURE WAS REOPENED AT BEDSIDE, REVEALING GLOBALLY HYPOPERFUSED ORGANS BUT NO DEFINITIVE SOURCE OF SEPSIS. FOLLOWING CONTINUED INSTABILITY AND AFTER DISCUSSION WITH HER FAMILY, THE PATIENT'S CODE STATUS WAS CHANGED TO DO NOT RESUSCITATE (COMFORT CARE). SHE WAS PRONOUNCED DEAD AT 10:14AM. THE PATIENT'S DEATH CERTIFICATE LISTED CARDIAC ARREST, SEPTIC SHOCK, BILE DUCT INJURY, BILE DUCT STRICTURE, AND A PANCREATIC BILIARY PERFORATION, EVEN THOUGH NO PERFORATION HAD BEEN IDENTIFIED DURING THE MULTIPLE SCOPES PERFORMED WHILE SHE WAS ALIVE. THE AUTOPSY PERFORMED FOUND MULTIFOCAL NECROSIS OF THE PANCREATIC PARENCHYMA, FAT NECROSIS WITH SAPONIFICATION, AND ACUTE VASCULAR THROMBOSIS CONSISTENT WITH ACUTE NECROTIZING PANCREATITIS POST-ERCP. THE IMMEDIATE CAUSE OF DEATH WAS DETERMINED TO BE POST-ERCP ACUTE NECROTIZING PANCREATITIS COMPLICATED BY SEPSIS DUE TO DELAYED ANTIBIOTIC ADMINISTRATION, SURGICAL DEVICE MALFUNCTION, AND FAILURE TO IDENTIFY OR TREAT A PERFORATION. ADDITIONAL INFORMATION RECEIVED ON APRIL 17, 2026. ON (B)(6) 2025, AFTER A SMALL DORSAL PANCREATIC SPHINCTEROTOMY WAS PERFORMED, OOZING FROM THE SPHINCTEROTOMY APEX WAS OBSERVED AND CONTROLLED WITH ARGON PLASMA COAGULATION. THE PANCREATIC DUCT WAS DILATED WITH 4 MM X 4 CM BALLOON, AND A 5 FR X 15 CM STRAIGHT PLASTIC STENT WAS PLACED IN THE PANCREATIC DUCT. A WIRE-GUIDED BILIARY CANNULATION WAS PERFORMED. THE CHOLANGIOGRAM SHOWED THE DILATED COMMON DUCT WITH NO FILLING DEFECTS DOWN TO INTERMEDIATE-GRADE, DISTAL, COMMON DUCT STRICTURE WITH DELAYED CONTRAST DRAINAGE. BILIARY SPHINCTEROTOMY WAS EXTENDED AND A 7FRX5CM DOUBLE PIGTAILED PLASTIC STENT WAS PLACED IN THE COMMON DUCT. SATISFACTORY CONTRAST DRAINAGE OBSERVED IN BOTH THE PANCREAS AND COMMON DUCT. ON THE MORNING OF (B)(6) 2025, THE POST-ERCP ZOSYN WAS ORDERED. A CT SCAN SHOWED SMALL-VOLUME GAS AND LIQUID IN PERITONEUM AND RETROPERITONEUM. NO EVIDENCE OF EITHER PERITONEAL OR RETROPERITONEAL PERFORATION WAS FOUND ON AN INTRA-OPERATIVE LEAK TEST. A ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED. SOME HYPEREMIA WAS NOTED AT THE AREA OF THE AMPULLA, BUT THERE WAS NO OVERT INJURY. A 19 F ROUND DRAIN WAS PLACED THROUGH THE RIGHT UPPER QUADRANT AND LAY THIS OVER THE AREA OF THE DUODENUM AND PANCREAS. A LAPAROTOMY PAD WAS LEFT IN THE RIGHT RETROPERITONEUM. A TEMPORARY ABDOMINAL CLOSURE WAS PLACED. THE PATIENT WAS INTUBATED IN CRITICAL CONDITION. NO COMPLICATIONS WERE APPARENT AT THE END OF THE CASE. ON (B)(6) 2025 AT 9:20AM TO 9:35AM, A BEDSIDE LAPAROTOMY WAS DONE WITH TEMPORARY ABDOMINAL CLOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14166 | AUTOTOME - SPHINCTEROTOMES | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention| O| D| H |