Hydratome RX 44 M00583040Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 08714729755197), received between Aug 7, 2017 and Mar 5, 2026 — classified as 3 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Break” (69 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-0759-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRATOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA OF DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE SPHINCTEROTOME WAS BOWED AND THE PAPILLOTOMY WAS WIDENED, THE CUTTING WIRE SNAPPED. 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 24527092 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN HYDRATOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TOME WIRE WAS BROKEN DURING SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX 44. 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 23544751 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE HEPATOPANCREATIC BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON MAY/JUNE. THE SPECIFIC DATE IS UNKNOWN. AFTER THE PROCEDURE, PATIENT COMING BACK IN WITH DELAYED BLEEDING FROM THE SPHINCTEROTOMY DUE TO THE INCORRECT ERBE SETTINGS. THE BLEEDING WAS TREATED WITH ENDOSCOPIC HEMOSTASIS. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AT THE TIME OF EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23327672 ↗
• MalfunctionAug 7, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS INSPECTED UPON RECEIVING ON JULY 16, 2025. DURING THE INSPECTION OF THE DEVICE, IT WAS NOTED THAT MOISTURE WAS PRESENT INSIDE THE STERILE PACKAGE. THERE WERE NO PATIENT AND PROCEDURE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739854 ↗
• MalfunctionJul 15, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THERE ARE HOLES IN THE PACKAGING. A PHOTO OF THE STERILE POUCH OF THE DEVICE WAS PROVIDED AND SHOWED THAT THE STERILE POUCH WAS TORN. THE PRODUCT WAS NOT USED IN A PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503777 ↗
• MalfunctionJul 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THERE ARE HOLES IN THE PACKAGING. A PHOTO OF THE STERILE POUCH OF THE DEVICE WAS PROVIDED AND SHOWED THAT THE STERILE POUCH WAS TORN. THE PRODUCT WAS NOT USED IN A PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503776 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER GAINING ACCESS TO THE COMMON BILE DUCT (CBD), SPHINCTEROTOMY WAS ATTEMPTED. THE DEVICE WAS BOWED DURING CUTTING AND THE CUT WIRE OF THE HYDRATOME 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323527 ↗
• MalfunctionJun 9, 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 HYDRATOME RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NURSE WAS BENDING THE CUTTING WIRE AS THE PHYSICIAN WAS PERFORMING SPHINCTEROTOMY. THE DEVICE WAS ENERGIZED AND THE CUTTING WIRE OF THE HYDRATOME RX 44 BROKE. 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 A DIFFERENT 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165416 ↗
• MalfunctionJun 3, 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 HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. A PHOTO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED AND SHOWED THAT THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137606 ↗
• MalfunctionMar 5, 2025Break; 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 HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE DEVICE SPARKED AND THE CUTTING WIRE OF THE HYDRATOME 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528662 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS BEING PREPARED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, UPON OPENING THE PACKAGE IT WAS OBSERVED THAT THE CUTTING WIRE WAS BROKEN OFF THE TOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685582 ↗
• MalfunctionOct 16, 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 HYDRATOME RX 44 WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HYDRATOME 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 HYDRATOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463499 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE HYDRATOME BROKE ON ONE END LEAVING THE OTHER END HANGING. IT WAS REPORTED THAT THE NO PART 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 20183823 ↗
• 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 HYDRATOME RX 44 WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. 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 HYDRATOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007307 ↗
• MalfunctionJul 29, 2024Break; Failure to Fold; Adverse Event Without Identified Device or Use Problem; Break; Failure to Fold; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HYDRATOME WAS ROTATED THREE TIMES IN EACH DIRECTION DURING CANNULATION WHILE NOT IN CONTACT WITH THE TISSUE. SPHINCTEROTOMY WAS THEN PERFORMED. THE PHYSICIAN ASKED TO BOW THE DEVICE; HOWEVER, IT DID NOT BOW. WHEN THE DEVICE WAS REMOVED INTO THE DUODENUM, IT WAS NOTICED THAT THE CUTING WIRE WAS BROKEN. IT WAS REPORTED THAT THE NO PART 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 19849085 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS BEING PREPARED FOR USE IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2024. DURING PREPARATION OUTSIDE THE PATIENT, UPON BOWING THE HANDLE OF THE DEVICE, THE CUTTING WIRE BROKE AT THE TIP. 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 19815478 ↗
• MalfunctionJun 11, 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 HYDRATOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE BROKE DURING BOWING WHILE BEING ENGAGED WITH AMPULLA. THE HYDRATOME RX 44 WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE CUTTING WIRE STILL ATTACHED ON ONE END. 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508166 ↗
• MalfunctionMay 22, 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 HYDRATOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) AND AMPULLA DURING A SPHINCTEROTOMY AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE PERFORMING SPHINCTEROTOMY, AFTER USING THE CAUTERY, THE END OF THE CUTTING WIRE BROKE OFF. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED FROM THE SCOPE AS IT WAS NO LONGER NEEDED TO ENLARGE THE OPENING OF THE AMPULLA. THE SPHINCTEROTOMY PROCEDURE WAS ALREADY 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 19368990 ↗
• MalfunctionJan 12, 2024Break; Material Deformation; Break; Material Deformation

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HYDRATOME RX 44 USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IN ORDER TO PERFORM SPHINCTEROTOMY, THE PHYSICIAN ASKED THE NURSE TO BOW THE DEVICE. AS SOON AS THE PHYSICIAN PRESSED THE FOOT PEDAL OF THE DIATHERMY MACHINE, THE CUTTING WIRE BROKE. A SECOND HYDRATOME RX 44 WAS USED; HOWEVER, THE SAME PROBLEM HAPPENED. 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 18500739 ↗
• MalfunctionJan 12, 2024Break; Material Deformation; Break; Material Deformation

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO HYDRATOME RX 44 USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IN ORDER TO PERFORM SPHINCTEROTOMY, THE PHYSICIAN ASKED THE NURSE TO BOW THE DEVICE. AS SOON AS THE PHYSICIAN PRESSED THE FOOT PEDAL OF THE DIATHERMY MACHINE, THE CUTTING WIRE BROKE. A SECOND HYDRATOME RX 44 WAS USED; HOWEVER, THE SAME PROBLEM HAPPENED. 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 18500738 ↗
• MalfunctionOct 16, 2023Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN PERFORMED SPHINCTEROTOMY AND HE NOTICED THAT THE CUTTING WIRE DID NOT BOW ENOUGH. IT WAS VERY FLAT, AND THEN ATTEMPTED TO CUT, IT WOULD JUST CAUTERIZE, RATHER THAN CUT. IT WAS REPORTED THAT THE CUTTING WIRE OF THE DEVICE FULLY EXITED THE SCOPE, AND IT DID NOT TOUCH THE ELEVATOR OF THE ENDOSCOPE. THE DEVICE WAS REMOVED FROM THE SCOPE, AND IT WAS NOTED THAT THE CUTTING WIRE DETACHED FROM THE BLUE TIP AND WAS PUSHED INTO THE TOME WHERE ABOUT 1/2 CM OF CUT WIRE WAS STICKING OUT. THERE WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17945322 ↗
• MalfunctionOct 5, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO SECOND OF FOUR HYDRATOME RX 44 USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE HYDRATOME RX 44 WAS INSERTED THROUGH THE DUODENOSCOPE. AFTER THE DEVICE EXITED THE DUODENOSCOPE, THE PHYSICIAN HAD DIFFICULTY PASSING THE GUIDEWIRE THROUGH THE TOME DUE TO FRICTION. THE SAME PROBLEM HAPPENED WHEN THE PHYSICIAN OPENED THREE MORE HYDRATOME RX 44. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RELOAD THE GUIDEWIRE THROUGH THE TOME AFTER FLUSHING THE TOME WITH SALINE AND WETTING THE GUIDEWIRE; HOWEVER, THE SAME PROBLEM WAS STILL NOTICED. IT WAS ALSO NOTED THAT THE PATIENT HAD A VERY DIFFICULT ANATOMY TO CANNULATE (PERIAMPULLARY DIVERTICULA AND A DUODENAL MUCOSAL FOLD) PARTIALLY BLOCKING THE VIEW OF THE AMPULLA. THE PHYSICIAN WAS ABLE TO PLACE A PANCREATIC DUCT STENT; HOWEVER, THE PROCEDURE WAS RESCHEDULED, AND A SECOND PROCEDURE WAS PERFORMED, TREATING THE BILIARY LEAK AND IT WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881612 ↗
• MalfunctionOct 5, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO FOURTH OF FOUR HYDRATOME RX 44 USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE HYDRATOME RX 44 WAS INSERTED THROUGH THE DUODENOSCOPE. AFTER THE DEVICE EXITED THE DUODENOSCOPE, THE PHYSICIAN HAD DIFFICULTY PASSING THE GUIDEWIRE THROUGH THE TOME DUE TO FRICTION. THE SAME PROBLEM HAPPENED WHEN THE PHYSICIAN OPENED THREE MORE HYDRATOME RX 44. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RELOAD THE GUIDEWIRE THROUGH THE TOME AFTER FLUSHING THE TOME WITH SALINE AND WETTING THE GUIDEWIRE; HOWEVER, THE SAME PROBLEM WAS STILL NOTICED. IT WAS ALSO NOTED THAT THE PATIENT HAD A VERY DIFFICULT ANATOMY TO CANNULATE (PERIAMPULLARY DIVERTICULA AND A DUODENAL MUCOSAL FOLD) PARTIALLY BLOCKING THE VIEW OF THE AMPULLA. THE PHYSICIAN WAS ABLE TO PLACE A PANCREATIC DUCT STENT; HOWEVER, THE PROCEDURE WAS RESCHEDULED, AND A SECOND PROCEDURE WAS PERFORMED, TREATING THE BILIARY LEAK AND IT WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881555 ↗
• MalfunctionOct 5, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO THIRD OF FOUR HYDRATOME RX 44 USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE HYDRATOME RX 44 WAS INSERTED THROUGH THE DUODENOSCOPE. AFTER THE DEVICE EXITED THE DUODENOSCOPE, THE PHYSICIAN HAD DIFFICULTY PASSING THE GUIDEWIRE THROUGH THE TOME DUE TO FRICTION. THE SAME PROBLEM HAPPENED WHEN THE PHYSICIAN OPENED THREE MORE HYDRATOME RX 44. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RELOAD THE GUIDEWIRE THROUGH THE TOME AFTER FLUSHING THE TOME WITH SALINE AND WETTING THE GUIDEWIRE; HOWEVER, THE SAME PROBLEM WAS STILL NOTICED. IT WAS ALSO NOTED THAT THE PATIENT HAD A VERY DIFFICULT ANATOMY TO CANNULATE (PERIAMPULLARY DIVERTICULA AND A DUODENAL MUCOSAL FOLD) PARTIALLY BLOCKING THE VIEW OF THE AMPULLA. THE PHYSICIAN WAS ABLE TO PLACE A PANCREATIC DUCT STENT; HOWEVER, THE PROCEDURE WAS RESCHEDULED, AND A SECOND PROCEDURE WAS PERFORMED, TREATING THE BILIARY LEAK AND IT WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881539 ↗
• MalfunctionOct 5, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO FIRST OF FOUR HYDRATOME RX 44 USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE HYDRATOME RX 44 WAS INSERTED THROUGH THE DUODENOSCOPE. AFTER THE DEVICE EXITED THE DUODENOSCOPE, THE PHYSICIAN HAD DIFFICULTY PASSING THE GUIDEWIRE THROUGH THE TOME DUE TO FRICTION. THE SAME PROBLEM HAPPENED WHEN THE PHYSICIAN OPENED THREE MORE HYDRATOME RX 44. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RELOAD THE GUIDEWIRE THROUGH THE TOME AFTER FLUSHING THE TOME WITH SALINE AND WETTING THE GUIDEWIRE; HOWEVER, THE SAME PROBLEM WAS STILL NOTICED. IT WAS ALSO NOTED THAT THE PATIENT HAD A VERY DIFFICULT ANATOMY TO CANNULATE (PERIAMPULLARY DIVERTICULA AND A DUODENAL MUCOSAL FOLD) PARTIALLY BLOCKING THE VIEW OF THE AMPULLA. THE PHYSICIAN WAS ABLE TO PLACE A PANCREATIC DUCT STENT; HOWEVER, THE PROCEDURE WAS RESCHEDULED, AND A SECOND PROCEDURE WAS PERFORMED, TREATING THE BILIARY LEAK AND IT WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881392 ↗