Autotome™ RX 44 M00545180Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 08714729444756), received between Aug 7, 2017 and May 5, 2026 — classified as 1 death, 4 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (42 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE INSERTED THROUGH THE DESIGNATED CHANNEL. THE PROCEDURE COULD NOT BE INITIATED. 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 25084733 ↗
• MalfunctionApr 3, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE WIRE BREAKS DURING ENDOSCOPIC SPHINCTEROTOMY (EST). IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE WAS 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 24778322 ↗
• MalfunctionNov 14, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED IN THE VATER'S PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE BENDING FUNCTION OF THE SPHINCTEROTOME WAS ACTIVATED, IT BEGAN TO TWIST TO THE SIDE INSTEAD OF BENDING. THE CUTTING EDGE BENT IN THE OPPOSITE DIRECTION THAN IT SHOULD HAVE. A PHOTO OF THE DEVICE SHOWED IT WAS BOWING OUT OF PLANE, THE CUTTING WIRE WAS KINKED, AND THE WORKING LENGTH MATERIAL WAS TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562950 ↗
• MalfunctionNov 6, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT (CBD) STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DREAMTOME RX 44 WEAS USED BUT, THE CUTTING WIRE BROKE THE MOMENT THE WIRE WAS ENERGIZED. AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED BUT, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE OF EITHER DEVICE DETACHED OR FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493471 ↗
• MalfunctionNov 3, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) BILIARY DUCT CANNULATION PROCEDURE TO TREAT JAUNDICE AND BILE DUCT STRICTURE DUE TO LITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 44 COMPLETELY BROKE AT THE PROXIMAL END AFTER STRETCHING. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED STILL COMPLETED WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE PROVIDED BY THE CUSTOMER OUTSIDE THE PATIENT SHOWS THE CUTTING WIRE BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459624 ↗
• MalfunctionJul 23, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE CUSTOMER WHERE IT CAN BE OBSERVED THAT THE CUTTING WIRE WAS BROKEN AND KINKED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576765 ↗
• MalfunctionJun 12, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 44 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: 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 22197202 ↗
• MalfunctionMar 21, 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 AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA OF VATER (AOV) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. 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 AUTOTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665698 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE BROKE INSIDE THE PATIENT WHEN THE PHYSICIAN ATTEMPTED TO CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792971 ↗
• 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 AN AUTOTOME RX 44 WAS USED IN THE PAPILLA VATERII DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN THE PAPILOTOME WAS FIRST TIGHTENED. A PHOTO WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE CUTTING WIRE WAS BROKEN. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170962 ↗
• MalfunctionJul 1, 2024Failure to Align; Adverse Event Without Identified Device or Use Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE CUTTING WIRE WOULD NO LONGER RELAX, CAUSING IT TO REMAIN BENT. IT WAS REPORTED THAT THE DEVICE DID BOW CORRECTLY BUT WOULD NOT RELEASE THE BOW (UNBOW). 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 19646827 ↗
• MalfunctionJan 9, 2024Break; Device Dislodged or Dislocated; Material Split, Cut or Torn; Break; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS BEING PREPARED FOR USE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION OUTSIDE THE PATIENT, THE CUTTING WIRE OF THE AUTOTOME RX 44 BROKE. 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 18480159 ↗
• MalfunctionJan 9, 2024Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AFTER THE HANDLE WAS ACTUATED AND BOWED THE DEVICE TO A DESIRED POSITION, IT WAS NOTICED THAT THE CUTTING WIRE WOULD NOT RELEASE THE BOW DESPITE SEVERAL ATTEMPTS OF RELAXING THE WIRE. IT WAS REPORTED THAT THE DEVICE WAS NOT ENERGIZED WHEN THE PROBLEM WAS NOTICED. 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 DEVICE IN A BOWED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477366 ↗
• MalfunctionNov 3, 2023Failure to Align; Material Deformation; Failure to Align; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE PAPILLA VATERI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, UPON CANNULATING THE PAPILLA, IT WAS NOTICED THAT THE DEVICE REMAINED IN A BOWED POSITION AND WOULD NOT RELEASE THE BOW. THEY TRIED TO BOW AND UNBOW THE DEVICE, BUT NOTHING HAPPENED. THE HANDLE HAD NO TENSION. 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 DEVICE IN A BOWED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067290 ↗
• MalfunctionNov 3, 2023Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE PAPILLA VATERI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, UPON CANNULATING THE PAPILLA, AFTER SEVERAL ATTEMPTS OF ACTUATING THE DEVICE, IT WAS NOTICED THAT THE DEVICE REMAINED IN A BOWED POSITION AND WOULD NOT RELEASE THE BOW. ALTHOUGH THE HANDLE WAS MOVABLE, BUT STILL THE DEVICE WOULD NOT RELEASE THE BOW. IT WAS REPORTED THAT THE DEVICE WAS NOT YET ENERGIZED FOR CUTTING. 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 18067074 ↗
• MalfunctionSep 18, 2023Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHILE CUTTING, THE CUTTING WIRE OF THE AUTOTOME RX 44 BROKE. THE WORKING LENGTH WAS ALSO TWISTED, WHICH RESULTED TO A WRONG ORIENTATION. 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 17769810 ↗
• MalfunctionSep 18, 2023Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHILE CUTTING, THE CUTTING WIRE OF THE AUTOTOME RX 44 BROKE. THE WORKING LENGTH WAS ALSO TWISTED, WHICH RESULTED TO A WRONG ORIENTATION. 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 17769753 ↗
• MalfunctionSep 18, 2023Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHILE CUTTING, THE CUTTING WIRE OF THE AUTOTOME RX 44 BROKE. THE WORKING LENGTH WAS ALSO TWISTED, WHICH RESULTED TO A WRONG ORIENTATION. 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 17769643 ↗
• MalfunctionSep 18, 2023Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHILE CUTTING, THE CUTTING WIRE OF THE AUTOTOME RX 44 BROKE. THE WORKING LENGTH WAS ALSO TWISTED, WHICH RESULTED TO A WRONG ORIENTATION. 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 17769523 ↗
• MalfunctionSep 18, 2023Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHILE CUTTING, THE CUTTING WIRE OF THE AUTOTOME RX 44 BROKE. THE WORKING LENGTH WAS ALSO TWISTED, WHICH RESULTED TO A WRONG ORIENTATION. 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 17768120 ↗
• MalfunctionAug 30, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE PAPILLA WAS CANNULATED, AND THE DEVICE WAS POSITIONED TO CUT. UPON FIRST APPLICATION OF CAUTERY, THE CUT WIRE OF THE AUTOTOME RX 44 BROKE ON THE PROXIMAL END. 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 17656207 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE AMPULLA OF VATER (AOV) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE AUTOTOME RX 44 WAS BOWED, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE 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 17494981 ↗
• MalfunctionJul 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS INTENDED TO BE USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE WIRE ANCHOR OF THE AUTOTOME RX 44 DISLODGED FROM THE CATHETER. 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 17347154 ↗
• MalfunctionApr 21, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 44 BROKE WHEN THEY STARTED THE PAPILLOTOMY. 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 AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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 16786903 ↗
• InjuryFeb 22, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX BROKE OFF. THE CUTTING WIRE WAS STILL ATTACHED BUT THE OTHER END BROKE OFF. IT WAS REPORTED THAT THERE WAS A PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT, WHICH SUCCESSFULLY RETRIEVED. IT WAS UNKNOWN WHAT DEVICE WAS USED TO RETRIEVE THE DETACHED PIECE. 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 16422442 ↗