TRUEtome 44 M00584180Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 08714729827641), received between May 22, 2017 and Sep 14, 2026 — classified as 2 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Break” (91 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 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763510 ↗
• MalfunctionSep 14, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763509 ↗
• MalfunctionSep 14, 2026Break; Use of Device Problem

  It was reported to Boston Scientific Corporation that a TRUEtome 44 was attempted to be used in the Papilla during an Endoscopic Retrograde Cholangiopancreatography procedure to treat Stones performed on (b)(6)2026.During the procedure, the cutting wire broke when performing sphincterotomy and the wire was lodged in the tissue. It was reported that a part of the cutting wire detached and fell into the patient and was eventually retrieved by pulling on the tome. 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 stable.Note: The Instructions For Use (IFU) indicates that the sphincterotome does not need to be energized prior to performing sphincterotomy. Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity. However, the customer reported that the device was energized prior to bowing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754099 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE WIRE HAD BROKEN AT THE MIDPOINT. AS THE DEVICE WAS CAREFULLY WITHDRAWN FROM THE SCOPE, A PORTION OF THE WIRE WAS SEEN PROTRUDING. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE CUSTOMER ALSO PROVIDED A VIDEO FROM THE PROCEDURE SHOWING THE DEVICE INSIDE THE PATIENT THAT THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO 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 25222688 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME 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 24927597 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE PAPILLA DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE CATHETER WAS CANNULATED INTO THE PAPILLA, IT WAS TIGHTENED TWICE. DURING THE SECOND TIGHTENING, THE CUTTING WIRE AT THE END OF THE CATHETER BROKE. 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 24859455 ↗
• MalfunctionFeb 23, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN A PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE DEVICE BROKE AND THE METAL PART CAME LOOSE. IT WAS REPORTED THAT IT WAS POSSIBLE TO REMOVE THE DETACHED PART BEFORE IT FELL INTO THE CAVITY. 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 24424129 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS DISCONNECTED. 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 REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291046 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT (CBD) STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME BROKE IMMEDIATELY UPON INSERTION, RENDERING THE DEVICE UNUSABLE. 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 DUE TO 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 24277972 ↗
• MalfunctionJan 2, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN ENERGY WAS APPLIED, THE CUTTING WIRE BROKE AFTER ABOUT FIVE SECONDS. THE PROCEDURE WAS STILL COMPLETED WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944298 ↗
• MalfunctionNov 25, 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 TRUETOME 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE OF THE DEVICE SNAPPED AFTER ONE FULL BOW INSIDE THE PATIENT. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. HOWEVER, THE BROKEN CUTTING WIRE SCRATCHED THE AMPULLA OF THE PATIENT AND CAUSED BLEEDING. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 23649936 ↗
• MalfunctionNov 14, 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 TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA AND COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CBD STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS INTENDING TO PERFORM SPHINCTEROTOMY AND THE WIRE WAS NOTED TO BE BROKEN AND UNABLE TO CUT. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559258 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME 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 23328509 ↗
• MalfunctionSep 27, 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 TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2025 DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME 44 BROKE INSIDE THE PATIENT'S BILE DUCT. IT WAS REPORTED THAT A PORTION THE CUT WIRE BROKE AT APPROXIMATELY 5 CM, AND THEY WERE ABLE TO REMOVE THE DEVICE WITHOUT IT BEING FREE IN THE CAVITY. 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 23162478 ↗
• MalfunctionAug 6, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STENOSIS IN THE BILE DUCT PERFORMED ON (B)(6) 2025. EVENT SUMMARY: DURING THE PROCEDURE, WHEN TIGHTENING THE SHEATH WIRE TO CUT THE PAPILLA, 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. PATIENT STATUS: THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734608 ↗
• MalfunctionJul 16, 2025Failure to Conduct; Failure to Conduct

  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 TRUETOME 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS USING A TRUETOME TO PERFORM SPHINCTEROTOMY. PADS WERE SET UP AND CAUTERY MACHINE SECURED. AS THE PHYSICIAN WAS PERFORMING THE CUTTING, THE DEVICE DID NOT CUT, AND NO BURNING SEEN IN THE AMPULLA. THE PHYSICIAN THEN TRIED WITH ANOTHER TRUETOME WITH THE SAME RESULTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527517 ↗
• MalfunctionJul 16, 2025Failure to Conduct; Failure to Conduct

  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 TRUETOME 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS USING A TRUETOME TO PERFORM SPHINCTEROTOMY. PADS WERE SET UP AND CAUTERY MACHINE SECURED. AS THE PHYSICIAN WAS PERFORMING THE CUTTING, THE DEVICE DID NOT CUT, AND NO BURNING SEEN IN THE AMPULLA. THE PHYSICIAN THEN TRIED WITH ANOTHER TRUETOME WITH THE SAME RESULTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527514 ↗
• MalfunctionJun 26, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY TRACT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A SPHINCTEROTOMY WAS PERFORMED. THE SPHINCTEROTOME WAS INSERTED DEEP INTO THE PAPILLA OF VATER. WHEN THE WIRE WAS BOWED BY THE NURSE, THE WIRE BROKE ON THE PROXIMAL SIDE OF THE CATHETER. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DOCTOR CONCLUDED THAT THE INCISION WAS SUFFICIENT AND COMPLETED THE PROCEDURE. PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED AND SHOW THE CUTTING WIRE IS 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 22337561 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA 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 TRUETOME 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327716 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA 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 TRUETOME 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327714 ↗
• MalfunctionMay 1, 2025Break; Break

  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 TRUETOME 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME 44 BROKE. 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 21946304 ↗
• MalfunctionMay 1, 2025Break; Break

  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 TRUETOME 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME 44 BROKE. 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 21946146 ↗
• MalfunctionJan 13, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN ENERGY WAS APPLIED THROUGH THE CUTTING WIRE, THE CUTTING WIRE BROKE AFTER ABOUT FIVE SECONDS. A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE CUTTING WIRE WAS BROKEN AND KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144803 ↗
• MalfunctionJan 13, 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 ATRUETOME 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN ENERGY WAS APPLIED THROUGH THE CUTTING WIRE, THE CUTTING WIRE BROKE AFTER ABOUT FIVE SECONDS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 21144174 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE DISCONNECTED. IT WAS REPORTED THAT THE CUTTING WIRE WAS BROKEN AND NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103427 ↗