Jagtome™ Revolution RX M00584260Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729953258), received between May 24, 2021 and Jan 20, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (24 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-0767-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DEVICE WAS BROKEN AND DID NOT WORK RIGHT FROM THE START. ADDITIONAL CLARIFICATION TO DETERMINE THE NATURE OF THE DAMAGE WAS NOT PROVIDED AND IS BEING REPORTED AS THE CUTTING WIRE MAY HAVE BEEN BROKEN. NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127170 ↗
• MalfunctionDec 30, 2025Break; 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 39 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE INTRAOPERATIVELY INSIDE THE PATIENT. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924130 ↗
• MalfunctionAug 23, 2025Break; 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 ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING 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 22880285 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. 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 22778231 ↗
• MalfunctionMar 21, 2025Failure to Align; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED THROUGH A DUODENOSCOPE. THE TECHNICIAN NOTED THAT THE SPHINCTEROTOME WAS ALREADY IN A BOWED POSITION, AND THE HANDLE WAS UNABLE TO ADJUST THE BOW ANGLE WHEN MOVED. IT WAS REPORTED THAT THE DEVICE COULD NOT BE UNBOWED OR RELEASED FROM THE BOWING POSITION. 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 21665694 ↗
• MalfunctionJan 13, 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 ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN TRYING TO BOW THE DISTAL PART OF THE SPHINCTEROTOME, THE WIRE ENDED UP DETACHING. IT WAS REPORTED THAT THE WIRE WAS INTACT BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. 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 21140607 ↗
• MalfunctionJan 8, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE PAPILLA DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX BROKE WHEN THE DEVICE WAS BOWED IN AN ATTEMPT TO CANNULATE. 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 OUTSIDE THE PATIENT AND INSIDE THE POUCH WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103451 ↗
• MalfunctionJan 8, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE PAPILLA DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX BROKE WHEN THE DEVICE WAS BOWED IN AN ATTEMPT TO CANNULATE. 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 OUTSIDE THE PATIENT AND INSIDE THE POUCH WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103422 ↗
• MalfunctionAug 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 AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER THE TOME WAS INTRODUCED, WHEN THE NURSE BOWED THE DEVICE, AND THEN THE CUTTING 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 20002284 ↗
• MalfunctionJan 12, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE SPHINCTER OF ODDI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE SPHINCTEROTOMY PROCEDURE, AFTER THE DEVICE WAS TENSIONED, 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 18505554 ↗
• MalfunctionJan 12, 2024Break; Material Deformation; Material Split, Cut or Torn; Break; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE SPHINCTER OF ODDI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2024. DURING THE SPHINCTEROTOMY PROCEDURE, AFTER THE DEVICE WAS TENSIONED, 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 18505470 ↗
• MalfunctionJan 12, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE SPHINCTER OF ODDI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2024. DURING THE SPHINCTEROTOMY PROCEDURE, AFTER THE DEVICE WAS TENSIONED, 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: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505437 ↗
• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AT THE END OF SPHINCTEROTOMY, THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692577 ↗
• MalfunctionJun 21, 2023Failure to Fold; Device Dislodged or Dislocated; Failure to Fold; Device Dislodged or Dislocated

  NOTE: THIS REPORT PERTAINS TO 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 IN THE DUODENUM TO ACCESS BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEREIN THE DUODENOSCOPE WAS POSITIONED WELL, THE JAGTOME REVOLUTION RX WAS INSERTED. WHEN TRYING TO CANNULATE, IT DID NOT BOW AS THE DISTAL END OF THE WIRE GOT DETACHED. A SECOND JAGTOME REVOLUTION RX WAS USED; HOWEVER, THE SAME PROBLEM HAPPENED. IT WAS REPORTED THAT IT WAS THE WIRE ANCHOR OF THE DEVICES THAT GOT DETACHED. ADDITIONALLY, NO PART OF THE DEVICES WAS 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 17172054 ↗
• MalfunctionJun 21, 2023Failure to Fold; Device Dislodged or Dislocated; Failure to Fold; Device Dislodged or Dislocated

  NOTE: THIS REPORT PERTAINS TO 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 IN THE DUODENUM TO ACCESS BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEREIN THE DUODENOSCOPE WAS POSITIONED WELL, THE JAGTOME REVOLUTION RX WAS INSERTED. WHEN TRYING TO CANNULATE, IT DID NOT BOW AS THE DISTAL END OF THE WIRE GOT DETACHED. A SECOND JAGTOME REVOLUTION RX WAS USED; HOWEVER, THE SAME PROBLEM HAPPENED. IT WAS REPORTED THAT IT WAS THE WIRE ANCHOR OF THE DEVICES THAT GOT DETACHED. ADDITIONALLY, NO PART OF THE DEVICES WAS 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 17171845 ↗
• MalfunctionApr 11, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A (B)(4) REVOLUTION RX WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, JUST THE FIRST CUT, THE CUTTING WIRE OF THE (B)(4) REVOLUTION RX BROKE. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS 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 16718763 ↗
• MalfunctionApr 11, 2023Break; Break

  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) 2023. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE DUODENUM THROUGH THE DUODENOSCOPE TO PERFORM PAPILLOTOMY. WHEN THE PHYSICIAN ACTIVATED THE GENERATOR, THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX BROKE. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS 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 16718257 ↗
• MalfunctionDec 28, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AFTER A SPHINCTEROTOMY, WHILE IN USE, THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX BROKE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064681 ↗
• MalfunctionDec 20, 2022Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Material Deformation

  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) 2022. DURING THE PROCEDURE, THE PHYSICIAN PERFORMED SPHINCTEROTOMY. WHEN SHE FINISHED HER CUT, THE TECHNICIAN FELT SOMETHING SNAP AND THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX BROKE. THE DEVICE WAS ALSO DIFFICULT TO REMOVE FROM THE SCOPE. 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: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE 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 16019188 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE DUODENUM DURING AN EXTRACTION OF GALLSTONES PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHILE THE DEVICE WAS ALREADY IN THE COMMON BILE DUCT, AND AS THE PHYSICIAN WAS ABOUT TO PERFORM SPHINCTEROTOMY, 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 15848156 ↗
• MalfunctionAug 10, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE BROKE INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199020 ↗
• MalfunctionJul 20, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHILE THE JAGTOME REVOLUTION RX WAS ENERGIZED TO PERFORM SPHINCTEROTOMY, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT THE CUTTING WIRE DETACHED BUT IT STAYED ATTACHED TO THE DEVICE. THE PHYSICIAN REMOVED THE DEVICE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067229 ↗
• MalfunctionMay 24, 2022Break; Failure to Fold; Device Dislodged or Dislocated; Break; Failure to Fold; Device Dislodged or Dislocated

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE JAGTOME REVOLUTION RX USED IN 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. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING MID PROCEDURE, WHEN THE PHYSICIAN BOWED THE DEVICE, IT DID NOT BOW, AND THEN THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX "BUSTED." IT WAS REPORTED THAT THE CUTTING WIRE BROKE, AND THE WIRE ANCHOR DISLODGED FROM THE CATHETER. A SECOND AND THIRD JAGTOME REVOLUTION RX WERE USED AND THE SAME THING HAPPENED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE OF THE THREE DEVICES 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491909 ↗
• MalfunctionMay 24, 2022Break; Failure to Fold; Device Dislodged or Dislocated; Break; Failure to Fold; Device Dislodged or Dislocated

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE JAGTOME REVOLUTION RX USED IN 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. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING MID PROCEDURE, WHEN THE PHYSICIAN BOWED THE DEVICE, IT DID NOT BOW, AND THEN THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX "BUSTED." IT WAS REPORTED THAT THE CUTTING WIRE BROKE, AND THE WIRE ANCHOR DISLODGED FROM THE CATHETER. A SECOND AND THIRD JAGTOME REVOLUTION RX WERE USED AND THE SAME THING HAPPENED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE OF THE THREE DEVICES 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491772 ↗
• MalfunctionMay 24, 2022Break; Failure to Fold; Device Dislodged or Dislocated; Break; Failure to Fold; Device Dislodged or Dislocated

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE JAGTOME REVOLUTION RX USED IN 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. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING MID PROCEDURE, WHEN THE PHYSICIAN BOWED THE DEVICE, IT DID NOT BOW, AND THEN THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX "BUSTED." IT WAS REPORTED THAT THE CUTTING WIRE BROKE, AND THE WIRE ANCHOR DISLODGED FROM THE CATHETER. A SECOND AND THIRD JAGTOME REVOLUTION RX WERE USED AND THE SAME THING HAPPENED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE OF THE THREE DEVICES 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491238 ↗