TRUEtome Jag 44 M00583100Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08714729858645), received between Dec 20, 2017 and Sep 10, 2026 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break; Deformation Due to Compressive Stress; Material Integrity Problem

  It was reported to Boston Scientific Corporation that a TRUEtome Jag 44 was being prepared for used in the Duodenal papilla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat Common bile duct stone to be performed on (b)(6)2026.During preparation, when the package was unpacked, it was found that the tip of the tome was split. Additionally, a photo of the complaint device was provided and showed that the cutting wire was broken and kinked. The procedure was completed with another of the same device.There was 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 50721272 ↗
• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094833 ↗
• MalfunctionJul 21, 2026Break; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894139 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLANGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT UPON THE INCISION THE SPHINCTEROTOME CUTTING WIRE SUDDENLY RUPTURED. 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 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 24706583 ↗
• MalfunctionFeb 11, 2026Break; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CBD STONES PERFORMED ON (B)(6) 2026. AFTER UNPACKING, IT WAS FOUND THAT THE CUTTING HEAD DEVIATED FROM THE CUTTING WIRE, AND THE INNER CORE OF THE HANDLE WAS FRACTURED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317094 ↗
• MalfunctionDec 8, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE PORTA HEPATIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION OUTSIDE THE PATIENT, IT WAS REPORTED THAT THE TIP OF THE TOME AND THE CUTTING WIRE WERE OFFSET, AND THE ATTEMPT TO INTUBATE WAS UNSUCCESSFUL. THE TIP OF THE TOME WAS NOT IN THE CORRECT POSITION WITH THE CUTTING WIRE; IT WAS IN A COILED SHAPE AND UNABLE TO BE ROTATED. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752500 ↗
• MalfunctionNov 24, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLELITHOTOMY PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE TIP OF THE CUTTING WIRE WAS SLIGHTLY TO THE RIGHT. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640454 ↗
• MalfunctionOct 6, 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 JAG 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE ELECTROTOMY WAS PERFORMED AFTER THE POWER SUPPLY WAS CONNECTED, THE CUTTING WIRE OF THE TOME WAS FRACTURED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME JAG 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23228359 ↗
• MalfunctionSep 26, 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 (BSC) THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, INCISION OF THE PAPILLA WAS PERFORMED AND THE CUTTING WIRE ON THE PROXIMAL SIDE OF THE DEVICE BROKE. A SECOND TRUETOME JAG 44 WAS ATTEMPTED TO BE USED BUT, DURING INCISION OF THE PAPILLA, THE CUTTING WIRE ALSO BROKE ON THE PROXIMAL SIDE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRES DETACHED AND FELL INTO THE PATIENT. PHOTOS OF THE COMPLAINT DEVICES OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND BOTH 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 23152023 ↗
• MalfunctionSep 25, 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 (BSC) THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, INCISION OF THE PAPILLA WAS PERFORMED AND THE CUTTING WIRE ON THE PROXIMAL SIDE OF THE DEVICE BROKE. A SECOND TRUETOME JAG 44 WAS ATTEMPTED TO BE USED BUT, DURING INCISION OF THE PAPILLA, THE CUTTING WIRE ALSO BROKE ON THE PROXIMAL SIDE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRES DETACHED AND FELL INTO THE PATIENT. PHOTOS OF THE COMPLAINT DEVICES OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND BOTH 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 23146254 ↗
• MalfunctionAug 28, 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 TRUETOME JAG 44 WAS PREPARED TO BE USE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION OUTSIDE THE PATIENT, THE DEVICE WAS UNPACKED, AND IT WAS NOTED THAT THE BOW COULD NOT BE OPENED NORMALLY. AFTER FORCING THE BOW TO BE OPENED, THE PLASTIC END KINKED AT 90 DEGREES. 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: VIDEO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWS THE WORKING LENGTH KINKED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920065 ↗
• MalfunctionAug 28, 2025Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN TRUETOME JAG 44 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE TRUETOME WAS NOT MANIPULATED. HOWEVER, THE TIP OF THE DEVICE DEFLECTED NATURALLY AND COULD NOT BE IN PLACED BY ROTATING THE HANDLE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920056 ↗
• MalfunctionJun 3, 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 JAG 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE FIRST INCISION OF THE PAPILLA, THE DEVICE WAS WITHDRAWN, AND DURING THE SECOND INCISION THE CUTTING WIRE WAS FRACTURED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME JAG 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134867 ↗
• MalfunctionMay 23, 2025Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE TRUETOME JAG 44 AND ONE JAGTOME RX 44 USED IN THE SAME PATIENT AND PROCEDURE. PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. EVENT SUMMARY: DURING THE PROCEDURE, THE CUTTING WIRE WAS CUT DURING SPHINCTEROTOMY. THE SAME PROBLEM OCCURRED WITH THE JAGTOME RX 44. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. PATIENT STATUS: THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081899 ↗
• MalfunctionMay 22, 2025Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS BENT. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT OF BROKEN CUTTING WIRE. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075422 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE PAPILLA OF THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN PULLED THE BOW IN PREPARATION FOR CUTTING BUT IT WAS FOUND THAT THE CUTTING WIRE OF THE TRUETOME JAG 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 22006341 ↗
• MalfunctionApr 23, 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 JAG 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN USED THE TRUETOME JAG 44 FOR CUTTING WHEN SUDDENLY THE CUTTING WIRE FRACTURED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891482 ↗
• MalfunctionApr 18, 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 JAG 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A TRUETOME JAG 44 WAS USED TO CUT THE PAPILLA. THE POWER SUPPLY WAS CONNECTED AND WHEN ENERGIZED, THE CUTTING WIRE BROKE AT THE PROXIMAL END AND COULD NOT CONTINUE. 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 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 21867987 ↗
• MalfunctionApr 15, 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 JAG 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TRUETOME WAS USED TO CUT THE PAPILLA AFTER THE INTUBATION. THE POWER SUPPLY WAS CONNECTED. UPON ENERGIZING, THE CUTTING WIRE OF THE TRUETOME JAG 44 BROKE AT THE REAR 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 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 21841000 ↗
• MalfunctionMar 7, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER SUCCESSFULLY COMPLETING THE INTUBATION, WHEN THE TOME WAS USED TO CUT THE PAPILLA, THE CUTTING WIRE WAS FRACTURED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME JAG 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549626 ↗
• MalfunctionDec 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME JAG 44 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON (B)(6) 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044518 ↗
• MalfunctionDec 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME JAG 44 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON DECEMBER 10, 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044511 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME JAG 44 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE. THE EXACT DATE OF THE EVENT IS UNKNOWN. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED AND SHOWED FOREIGN MATERIAL INSIDE THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685229 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME JAG 44 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE. THE EXACT DATE OF THE EVENT IS UNKNOWN. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED AND SHOWED FOREIGN MATERIAL INSIDE THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684872 ↗
• MalfunctionOct 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE SECOND PORTION OF THE DUODENUM AND PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE NURSE BOWED THE TOME, THE WIRE DETACHED FROM THE BACK OF THE TIP. IT WAS REPORTED THAT THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME JAG 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567758 ↗