Hydratome RX 44 M00583050Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729755203), received between Jan 23, 2018 and Nov 6, 2025 — classified as 3 injuries, 36 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-0761-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 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 HYDRATOME RX WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE WAS BROKEN UPON BOWING OF THE TOME IN PREPARING FOR SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. A PHOTO WAS PROVIDED OF THE DEVICE OUTSIDE THE PATIENT AND SHOWS THE CUTTING WIRE WAS BROKEN AND KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493852 ↗
• MalfunctionMar 19, 2025Break; 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 DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO TENSION THE DEVICE, THE CUTTING WIRE BROKE FROM THE BEGINNING OF USE. 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 21649280 ↗
• MalfunctionJun 18, 2024

  ERROR CODE "INTERNAL CHECK".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557425 ↗
• MalfunctionApr 25, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME 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, THE PHYSICIAN TOLD THE NURSE TO BOW AND UNBOW THE DEVICE AND STARTED TO CUT. HOWEVER, IT WAS NOTICED THAT ONE SIDE OF THE CUTTING WIRE OF THE HDYRATOME RX 44 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. 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 16804629 ↗
• MalfunctionJan 19, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE SMALL INTESTINE AND BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION PRIOR TO THE PROCEDURE, THE CUT WIRE SNAPPED UPON FIRST BOW. 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 16210497 ↗
• InjuryJan 19, 2023Failure to Fold; Material Separation; Detachment of Device or Device Component; Difficult to Advance; Failure to Fold; Material Separation; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE COLON DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, "THE SPHINCTEROTOME DID NOT DEPLOY (OPEN)" AND A STRONG RESISTANCE WAS ENCOUNTERED DURING THE DEPLOYMENT. IT WAS NOTICED THAT THERE WAS A PLASTIC PART LEFT INSIDE THE PATIENT'S COLON. THE PHYSICIAN HAD TO USE ANOTHER DEVICE TO RETRIEVE THE PLASTIC PART. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 27, 2023: UPON OPENING THE DEVICE DURING PREPARATION, THERE WERE NO DIFFICULTIES WITH THE GUIDEWIRE. HOWEVER, DURING THE PROCEDURE, THE NURSE HAD DIFFICULTY PUSHING THE GUIDEWIRE AND FELT AS IF THE GUIDEWIRE WAS BLOCKED. THE NURSE CONTINUED TO PUSH A LITTLE BIT HARDER, AND THE DISTAL TIP OF THE GUIDEWIRE DETACHED, BLOCKED THE DISTAL PART OF THE TOME, AND ENTERED THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX 44. NOTE: THE DISTAL TIP IS A BIOCOMPATIBLE HYDROPHILIC TIP THAT CAN BE PASSED NATURALLY BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206957 ↗
• MalfunctionSep 7, 2022Break; 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 PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, UPON CANNULATION USING THE HYDRATOME RX 44, THE PHYSICIAN ASKED THE TECHNICIAN TO BOW THE DEVICE. WHEN THE CURRENT WAS APPLIED TO THE DEVICE, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. ADDITIONALLY, THE SCOPE AND THE ANATOMY WERE IN NORMAL POSITIONS. 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 15373723 ↗
• MalfunctionMay 4, 2022Break; Break

  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) 2022. DURING THE PROCEDURE MID SPHINCTEROTOMY, 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 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 14281074 ↗
• MalfunctionMar 9, 2022Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HYDRATOME RX 44 USED IN THE SAME PROCEDURE. 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 PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE ENDOSCOPE WAS INSERTED AND POSITIONED INTO THE PATIENT. A HYDRATOME RX 44 WAS THEN INSERTED TO CANNULATE; HOWEVER, THE PRELOADED HYDRA JAGWIRE GUIDEWIRE WOULD NOT ADVANCE THROUGH THE TOME WITHOUT ALSO CAUSING THE TOME TO ADVANCE. A SECOND HYDRATOME RX 44 WAS USED, AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS REPORTED THAT THEY WOULD BRING THE PATIENT BACK TO ATTEMPT THE PROCEDURE AGAIN AND TRY A JAGTOME REVOLUTION DEVICE INSTEAD. THERE WAS NO INFORMATION AS TO WHEN THIS WOULD BE PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713098 ↗
• MalfunctionMar 9, 2022Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HYDRATOME RX 44 USED IN THE SAME PROCEDURE. 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 PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE ENDOSCOPE WAS INSERTED AND POSITIONED INTO THE PATIENT. A HYDRATOME RX 44 WAS THEN INSERTED TO CANNULATE; HOWEVER, THE PRELOADED HYDRA JAGWIRE GUIDEWIRE WOULD NOT ADVANCE THROUGH THE TOME WITHOUT ALSO CAUSING THE TOME TO ADVANCE. A SECOND HYDRATOME RX 44 WAS USED AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS REPORTED THAT THEY WOULD BRING THE PATIENT BACK TO ATTEMPT THE PROCEDURE AGAIN AND TRY A JAGTOME REVOLUTION DEVICE INSTEAD. THERE WAS NO INFORMATION AS TO WHEN THIS WOULD BE PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713045 ↗
• MalfunctionJan 26, 2022Break; 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) 2022. DURING THE PROCEDURE, 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 13359754 ↗
• MalfunctionNov 24, 2021Break; Break

  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) 2021. DURING THE PROCEDURE, BEFORE THEY PERFORMED PAPILLOTOMY, THE CUTTING WIRE OF THE HYDRATOME RX 44 BROKE INSIDE THE PATIENT. 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 12868765 ↗
• MalfunctionNov 24, 2021Break; Material Deformation; Break; Material Deformation

  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) 2021. DURING THE PROCEDURE, WHILE SPHINCTEROTOMY WAS PERFORMED, THE CUTTING WIRE OF THE HYDRATOME RX 44 BROKE AND DETACHED FROM THE TOME. 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 12868676 ↗
• MalfunctionSep 21, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE REMOVAL PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHEN THEY INITIATED ENERGIZATION FOR SPHINCTEROTOMY, 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 12506442 ↗
• MalfunctionAug 25, 2021Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS INTENDED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, BEFORE THE DEVICE WAS USED IN THE PATIENT, NEITHER SIDE OF THE PRELOADED GUIDEWIRE COULD BE ADVANCED THROUGH THE TIP OF THE TOME AND THE GUIDEWIRE WAS VERY DIFFICULT TO PUSH. AFTER FURTHER INSPECTION, IT WAS NOTICED THAT THE HYDRATOME RX 44 AND THE PRELOADED HYDRA JAGWIRE GUIDEWIRE WERE COATED IN A STRANGE SUBSTANCE. 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 WAS PROVIDED BY THE CUSTOMER SHOWING THE TOME AND THE GUIDEWIRE COATED WITH UNKNOWN SUBSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366024 ↗
• MalfunctionDec 30, 2020Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER GAINING ACCESS TO THE COMMON BILE DUCT AND BOWING THE DEVICE, IT WOULD NOT RELEASE THE BOW. THE TECHNICIAN TRIED TO EXTEND THE HANDLE MULTIPLE TIMES; HOWEVER, THE CUTTING WIRE WOULD STILL NOT UNBOW. THE SLIGHT BOW IN THE DEVICE MADE IT IMPOSSIBLE TO PUSH THE DEVICE UP THROUGH THE STRICTURE IN THE BILE DUCT. REPORTEDLY, THE DEVICE WAS NOT TESTED PRIOR TO USE AND THERE WAS NO VISIBLE DAMAGE NOTED. THE PROCEDURE WAS COMPLETE WITH A SECOND HYDRATOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11096985 ↗
• InjuryDec 23, 2020Adverse 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 DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THERE WAS "BUBBLING" DURING THE CUTTING PROCESS. IT WAS CONFIRMED THAT THERE WAS NO REPORTED MALFUNCTION OF THE HYDRATOME RX 44 DEVICE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. POST-ERCP PROCEDURE, THE PATIENT HAD DEVELOPED PANCREATITIS. THE EXACT EVENT DATE IS UNKNOWN. THE PATIENT'S HOSPITALIZATION WAS PROLONGED WITH ANTIBIOTIC THERAPY AND CONTINUOUS MONITORING. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF PANCREATITIS WAS DUE TO "EXCESSIVE INAPPROPRIATE COAGULATION" CAUSED BY THE "VECTOR OF COAGULATION POWER" BEING TOO HIGH. REPORTEDLY, THE SETTINGS OF THE ERBE VIO3 ELECTROSURGICAL UNIT (A NON -BSC DEVICE) WERE LOWERED SEEMINGLY RESOLVING THE REPORTED "EXCESSIVE INAPPROPRIATE COAGULATION." REPORTEDLY, THE PATIENT HAS BEEN GIVEN MORE INTENSIVE MEDICAL CARE.

  Patient problems: Inflammation

  MAUDE report 11069209 ↗
• MalfunctionNov 24, 2020Break; Failure to Fold; Break; Failure to Fold

  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 PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TOME WOULD NOT BOW LIKE NORMAL AND IT WAS NOTICED THAT THE CUTTING WIRE OF THE HYDRATOME RX 44 WAS BROKEN. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10895855 ↗
• MalfunctionNov 24, 2020Break; Break

  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), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN PERFORMED PAPILLOTOMY SUCCESSFULLY. THE TOME WAS REMOVED FROM THE ENDOSCOPE, AND A BALLOON SWEEP WAS PERFORMED. THE TOME WAS THEN ADVANCED BACK DOWN THE ENDOSCOPE IN ORDER TO PERFORM A SECOND, LARGER PAPILLOTOMY. WHEN THE PHYSICIAN PRESSED THE PEDAL FOR CAUTERY, THE CUT WIRE SNAPPED, AND ONE SIDE OF THE CUT WIRE BECAME UNATTACHED FROM THE TOME. REPORTEDLY, 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10891482 ↗
• MalfunctionOct 7, 2020Break; 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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY TRIED TO BOW THE TOME, THE CUTTING WIRE WAS DISCONNECTED FROM ONE PART OF THE TOME. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED 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 Consequences Or Impact To Patient

  MAUDE report 10641634 ↗
• MalfunctionSep 23, 2020Break; Break

  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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN THEY WERE BOWING. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED 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 Consequences Or Impact To Patient

  MAUDE report 10575213 ↗
• MalfunctionAug 31, 2020Break; Break

  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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE BROKE WHILE ACTIVELY PERFORMING A SPHINCTEROTOMY. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED 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 Consequences Or Impact To Patient

  MAUDE report 10471777 ↗
• MalfunctionAug 4, 2020Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED N THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE END OF THE CUTTING WIRE BROKE FROM THE TOME. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 Consequences Or Impact To Patient

  MAUDE report 10361147 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHICH CAUSED BLEEDING. THE PHYSICIAN ADMINISTERED 3CC OF EPINEPHRINE TO CONTROL THE BLEEDING WITH ADEQUATE RESULTS. ADDITIONALLY, THE PHYSICIAN REQUESTED A FLAT AND UPRIGHT X-RAY TO RULE OUT PERFORATION AND REPORTEDLY THE RESULTS WERE NORMAL. NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS 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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10215623 ↗
• MalfunctionMar 23, 2020Break; Break

  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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE AT THE PROXIMAL END OF THE CATHETER. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND HYDRATOME 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865595 ↗