Jagtome™ Revolution RX M00584240Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08714729953234), received between Mar 19, 2020 and Aug 13, 2026 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (31 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 22, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0765-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244651 ↗
• MalfunctionMay 6, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE WIRE BROKE ALONG THE WORKING LENGTH WHEN SPHINCTEROTOMY WAS INITIATED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094003 ↗
• MalfunctionApr 14, 2026Failure to Fold; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN (B)(6) 0F 2026. DURING THE PROCEDURE, IT WAS FOUND THAT THE CUTTING WIRE ON THE SPHINCTEROTOME WAS BENT AFTER THE DEVICE WAS ALREADY INSIDE THE PATIENT. THE PHYSICIAN DECLINED TO CHANGE THE DEVICE AS THE CAUTERY WORKED WITH THE TOME; THEY WERE JUST UNABLE TO BOW/BEND THE TOME ALL THE WAY. THE PROCEDURE WAS STILL COMPLETED USING THE SAME ORIGINAL DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876110 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHILE USING CAUTERY. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654024 ↗
• MalfunctionFeb 27, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WIRE BROKE OFF CATHETER WHILE THEY WERE ABOUT TO USE CAUTERY. THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471424 ↗
• MalfunctionFeb 2, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THEY TRIED TO BOW THE TOME AND THE WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242425 ↗
• MalfunctionJan 5, 2026Break; Deformation Due to Compressive Stress

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO JAGTOME REVOLUTION RX USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CUTTING WIRE BENT IN HALF AND COULDN'T BE USED FOR SPHINCTEROTOMY. IT WAS ALSO REPORTED THAT THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER. A SECOND JAGTOME REVOLUTION RX WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT CONDITION WAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 26, 2026: IT WAS REPORTED THAT ONLY ONE JAGTOME REVOLUTION RX HAD A WIRE ANCHOR DETACHED AND THE PROCEDURE WAS COMPLETED WITH THE SECOND OF THE SAME DEVICE. THE ANATOMY LOCATION INVOLVED WAS THE DUODENUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959972 ↗
• MalfunctionJan 5, 2026Break; Deformation Due to Compressive Stress

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO JAGTOME REVOLUTION RX USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CUTTING WIRE BENT IN HALF AND COULDN'T BE USED FOR SPHINCTEROTOMY. IT WAS ALSO REPORTED THAT THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER. A SECOND JAGTOME REVOLUTION RX WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT CONDITION WAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 26, 2026: IT WAS REPORTED THAT ONLY ONE JAGTOME REVOLUTION RX HAD A WIRE ANCHOR DETACHED AND THE PROCEDURE WAS COMPLETED WITH THE SECOND OF THE SAME DEVICE. THE ANATOMY LOCATION INVOLVED WAS THE DUODENUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959962 ↗
• MalfunctionAug 15, 2025Failure to Align; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Failure to Align; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED AND BOWED CORRECTLY BUT THE CUT WIRE ORIENTATION OUT OF THE SCOPE WAS OUT OF POSITION. AN ATTEMPT WAS MADE TO MANIPULATE THE TOME BY ROTATING THE HANDLE WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME REVOLUTION RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813056 ↗
• MalfunctionJul 28, 2025Break; Peeled/Delaminated; Material Deformation; Break; Peeled/Delaminated; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A JAGTOME REVOLUTION RX WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE TECH STRIPS THE WIRE TO THE PHYSICIAN, THE COATING OF THE GUIDEWIRE PEELED. THE CUTTING WIRE ALSO BROKE INSIDE THE DUCT. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDEWIRE AND A DIFFERENT SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. ADDITIONALLY, THE PTFE COATING OF THE GUIDEWIRE WAS ALSO PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639486 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN PERFORMING THE SPHINCTEROTOMY THE CUTTING WIRE BROKE OFF. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME REVOLUTION RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657554 ↗
• MalfunctionMar 12, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX WOULD NOT RAISE UP AND APPEARED TO BE LOOSE IN ONE END. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE WIRE/ANCHOR WAS DISLODGED OR DISLOCATED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588492 ↗
• MalfunctionFeb 26, 2025

  SPHINCTERTOME INSERTED THROUGH DUODENOSCOPE NOTED BY TECH THAT THE SPHINCTERTOME WAS IN "BOW" POSITION ALREADY AND SPHINCTERTOME HANDLE NOT BEING ABLE TO CHANGE BOW ANGLE WHEN MOVED. SEQUESTERED AND REPORTED TO BOSTON REP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468366 ↗
• MalfunctionJan 15, 2025Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TOME WAS HAVING DIFFICULTY BOWING AND THEN THE CUT WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME REVOLUTION RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161815 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS ON (B)(6) 2024. DURING THE PROCEDURE, THEY SET UP JAGTOME AS INSTRUCTED AND TESTED BOWING BEFORE HANDING TO PHYSICIAN TO PASS THROUGH SCOPE. ONCE TOME WAS OUT OF THE SCOPE, THEY STARTED ATTEMPTING CANNULATION. DURING THIS PROCESS, THE PHYSICIAN INSTRUCTED THEM TO BOW THE TOME FULLY AND AS THEY DID, THE CUTTING WIRE SNAPPED, AND THEY COULDN'T BOW. ACCOUNT STATED THAT THEY WERE NOT IN AN UNUSUAL ANGLE, NOR DID THEY ROTATE THE TOME AT ALL. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844337 ↗
• MalfunctionOct 9, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN STARTED THE SPHINCTEROTOMY, THE CUT WIRE OF THE JAGTOME REVOLUTION RX BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412357 ↗
• MalfunctionSep 20, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE DUODENUM AND COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN IT WAS FIRST ANGLED. THEY THEN CUT OFF THE TIP TO REMOVE THE WIRE AND PREVENT DAMAGE TO THE ENDOSCOPE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME REVOLUTION RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20274158 ↗
• MalfunctionSep 9, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170987 ↗
• MalfunctionSep 2, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN CURRENT WAS APPLIED TO THE DEVICE, THE CUTTING WIRE SNAPPED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED WITHOUT DAMAGE TO THE PATIENT AND THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117498 ↗
• MalfunctionAug 8, 2024Peeled/Delaminated; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO A JAGTOME REVOLUTION RX, ADVANIX PANCREATIC STENT AND NAVIFLEX PUSHER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN WANTS TO PLACE A PROPHYLACTIC PANCREATIC STENT TO REDUCE (ERCP) PANCREATITIS. THE PANCREATIC STENT WAS PUSHED OVER THE WIRE AND COULD NOT ADVANCE ALL THE WAY INTO THE DUCT. THEY THEN TRIED ANCHORING THE WIRE WITH THE SCOPE ELEVATOR AND THE WIRE'S JACKET STARTED RIPPING OFF THE WIRE. THEY TRIED FLUSHING THE SCOPE CHANNEL WITH WATER AND SALINE TO WET THE WIRE, BUT IT DID NOT WORK. EVENTUALLY THEY HAD TO PULL THE SCOPE OUT BECAUSE THE STENT WAS GOING TO BE LODGED IN THE SCOPE CHANNEL AND ENDED UP LOSING WIRE ACCESS ONCE THEY PULLED THE SCOPE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943005 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE JAGTOME WIRE SNAPPED DURING THE FIRST ACTIVATION OF CAUTERY FUNCTION TO PERFORM SPHINCTEROTOMY. NO FURTHER EVENT INFORMATION WAS PROVIDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630904 ↗
• MalfunctionMay 24, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO JAGTOME REVOLUTION RX USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE PERFORMING SPHINCTEROTOMY, THE CUTTING WIRE BROKE. A SECOND JAGTOME REVOLUTION RX WAS USED; HOWEVER, THE CUTTTING WIRE ALSO BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389846 ↗
• MalfunctionMay 24, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO JAGTOME REVOLUTION RX USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE PERFORMING SPHINCTEROTOMY, THE CUTTING WIRE BROKE. A SECOND JAGTOME REVOLUTION RX WAS USED; HOWEVER, THE CUTTTING WIRE ALSO BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389842 ↗
• MalfunctionMay 17, 2024Break; Failure to Conduct; Adverse Event Without Identified Device or Use Problem; Break; Failure to Conduct; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE BILE DUCT AND AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS SUCCESSFULLY CANNULATED AND WAS ADVANCED TO MAKE A SPHINCTEROTOMY. IT WAS NOTICED THAT THE PATIENT HAD A NON-BOSTON SCIENTIFIC PANCREATIC STENT STICKING OUT OF THE DUCT. THE DEVICE WAS TEMPORARILY ENERGIZED AND THEN IT COULD NOT BE ENERGIZED FOR ABOUT 1 TO 2 SECONDS. AN ATTEMPT WAS MADE TO RECONNECT THE DEVICE AND SWAPPED THE GENERATOR, AND THEN IT WAS NOTICED THAT THE WIRE WAS BROKEN. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. IN THE PHYSICIAN'S ASSESSMENT, SINCE HE NOTICED THE PANCREATIC STENT MARKER (MADE OF A RADIOPAQUE METAL) WAS RIGHT IN THE AREA OF WHERE THE CUTTING WIRE WAS PLACED, HE THOUGHT THAT THE METALLIC MARKER INTERFERED WITH ENERGIZING THE DEVICE AND CAUSED IT TO SNAP. THE TOME WAS PRESSED UP AGAINST THE PANCREATIC STENT WHILE IT WAS BEING ENERGIZED WITH MINIMAL BOWING. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME REVOLUTION RX.. THERE WERE NO PATIENT COMPLICATIONS REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339106 ↗
• MalfunctionApr 23, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE INSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169269 ↗