Dreamtome™ RX 44 M00584050Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 08714729778271), received between Jan 30, 2017 and Sep 15, 2026 — classified as 4 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Break” (96 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-0753-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Break; Difficult to Remove

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Loss of consciousness

  MAUDE report 50780240 ↗
• MalfunctionSep 12, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744706 ↗
• MalfunctionMay 6, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. IT WAS REPORTED THAT NO PARTS 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 25107652 ↗
• MalfunctionApr 30, 2026Failure to Align; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT BEFORE INSERTION OF THE TOME INTO THE BIOPSY PORT, THE PHYSICIAN NOTICED THAT THE TIP WAS VERY BOWED. THE ASSISTANT ATTEMPTED TO UNBOW IT, BUT THE CUTTING WIRE WILL NOT RELEASE THE BOW; IT MADE CANNULATION MORE DIFFICULT. IT WAS ALSO REPORTED THERE WAS A BIT OF RESISTANCE WHEN INJECTING CONTRAST. A PHOTO WAS PROVIDED FROM THE CUSTOMER, SHOWING THAT THE CUTTING WIRE WAS IN BOWED POSITION. IT WAS REPORTED THAT THE ORIGINAL METHOD AND DEVICE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 25038797 ↗
• MalfunctionApr 17, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE CUTTING WIRE BROKE WHILE BEING TENSIONED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED 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 A DIFFERENT 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906464 ↗
• MalfunctionMar 30, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CBD STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE ENDOSCOPIST ATTEMPTED TO FURTHER BOW THE INSTRUMENT TO INCREASE THE CUTTING ANGLE AND EXTEND THE SPHINCTEROTOMY, THE FILAMENT WIRE SNAPPED. IT WAS REPORTED THAT THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. IT WAS REPORTED THAT NO CUTTING WIRE WAS DETACHED INTO THE PATIENT. 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 24731880 ↗
• MalfunctionMar 25, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, IT WAS REPORTED THAT DEVICE WOULD NOT UNBOW COMPLETELY AND COULD NOT BE PUSHED DOWN THE CAP OF THE LOCKING DEVICE. THE PROCEDURE WAS COMPLETED USING 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 24690853 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575839 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570738 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570733 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570732 ↗
• MalfunctionMar 11, 2026Failure to Align; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, BOW ON THIS PARTICULAR SPHINCTEROTOME JUST WOULD NOT STRAIGHTEN OUT. IT COULD BOW UP FURTHER BUT NOT GO INTO THE UNBOWED SHAPE AS WOULD BE EXPECTED FROM THE SPHINCTEROTOMES AND THE MAINTAINED/PRONOUNCED CURVATURE AT THE END THEN MEANT THAT IT COULD NOT BE PUSHED DOWN THE CHANNEL THROUGH THE LOCKING DEVICE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 24570319 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570302 ↗
• MalfunctionMar 6, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE DIGESTIVE TRACT DURING A RETROGRADE BILIARY CATHETERIZATION PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, UPON INITIAL ACTIVATION OF THE SPHINCTEROTOME USING THE ERBE VIO 3 ELECTROSURGICAL UNIT, A SLIGHT DEPRESSION OF THE CUT PEDAL RESULTED IN AN UNEXPECTED BREAKAGE OF THE CUTTING WIRE. THE CLINICAL TEAM IMMEDIATELY RETRACTED THE BROKEN FILAMENT BACK INTO THE DUODENOSCOPE. NO LEAKS WERE DETECTED DURING POST PROCEDURE ENDOSCOPE REPROCESSING, INCLUDING LEAK TESTING. PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530601 ↗
• MalfunctionFeb 20, 2026Failure to Align; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALL STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DREAMTOME RX COULD NOT PASS THE BIOPSY PORT OF THE DUODENUM SCOPE BECAUSE THE CUTTING WIRE OF THE DREAMTOME STAYED IN A BOWED POSITION. 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 24398120 ↗
• MalfunctionJan 21, 2026Break; Failure to Fold; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY STONES PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE NURSE NOTICED THE DEVICE COULD NOT BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: WIRE DETACHED/SEPARATED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134233 ↗
• MalfunctionJan 7, 2026Failure to Align; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DREAMTOME RX 44 REMAINED BENT AND DID NOT UNBOW PROPERLY. IMPOSSIBLE TO STRAIGHTEN THE TOME. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED. INFORMATION RECEIVED ON DECEMBER 23, 2025: IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC CORPORATION (BSC) DEVICE AND THE ANATOMY LOCATION INVOLVED WAS DUODENUM, IN FRONT OF PAPILLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993097 ↗
• MalfunctionNov 24, 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 DREAMTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY STRICTURES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE BROKE WHILE CUTTING THE PAPILLOTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632942 ↗
• MalfunctionNov 6, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  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 A DREAMTOME 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. A PHOTO OF THE DEVICE WAS PROVIDED AND SHOWS THE CUTTING WIRE WAS BROKEN AND KINKED. 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 23493389 ↗
• MalfunctionOct 21, 2025Failure 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 A DREAMTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE CLEARANCE PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TOME WAS ALREADY BOWED UPON INSERTION INTO BIOPSY CHANNEL, EVEN WITH THE HANDLE STRETCHED OUT TO MAXIMUM THE TIP WOULD NOT STRAIGHTEN. THE TOME WOULD NOT UNBOW AND THE TIP WAS STUCK IN A CURVED SHAPE WITH THE CUTTING WIRE PROTRUDING. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE DEVICE IN A BOWING POSITION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350864 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DREAMTOME DEVICE WAS UNABLE TO MAKE A SUCCESSFUL CUT DESPITE SEVERAL ATTEMPTS USING THE ERBE MACHINE. UPON REMOVAL, THE PHYSICIAN DISCOVERED THAT THE METAL WIRE HAD BROKEN. 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 22818764 ↗
• MalfunctionJul 15, 2025Failure to Fold; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Fold; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE COULD NOT BE FULLY TENSIONED, WHICH PREVENTED A COMPLETE PAPILLOTOMY FROM BEING PERFORMED. SINCE FURTHER TENSIONING WAS NOT POSSIBLE, THE DEVICE WAS REMOVED FOR EXTERNAL INSPECTION. UPON EXAMINATION, IT WAS FOUND THAT THE CUTTING WIRE DID NOT EXTEND ACROSS THE FULL LENGTH OF THE TIP. THE CUTTING WIRE ENDED AT THE BROWN MARKING INSTEAD OF THE BLUE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. 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 A WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22515597 ↗
• MalfunctionJul 15, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY DISEASE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE CUTTING WIRE SNAPPED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED 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 DREAMTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509613 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CBD STONES PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE DEVICE WAS BOWED AND ENERGIZED BUT, DURING CUTTING THE WIRE TORE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22447925 ↗
• InjuryJul 8, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE DREAMTOME RX 44 BROKE AND FELL OFF THE PATIENT. IT WAS REPORTED THAT THE DETACHED CUTTING WIRE WAS SUCCESSFULLY RETRIEVED USING FORCEPS. 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 22438526 ↗