TRUEtome Jag 44 M00583140Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729858683), received between Oct 20, 2017 and Sep 9, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699121 ↗
• MalfunctionFeb 23, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TRUETOME WAS PUSHED INTO THE AMPULLA AND UPON PULLING IT OUT THE CUT WIRE CAME OFF FROM THE TRUETOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. A VIDEO WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE WIRE ANCHOR WAS DISLODGED. 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 WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423813 ↗
• 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 TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. 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 JAG 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165353 ↗
• MalfunctionFeb 26, 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 TRUETOME JAG 44 WAS USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME JAG 44 BROKE EVEN THOUGH IT WAS NOT FULLY TENSIONED. 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 18779303 ↗
• MalfunctionNov 25, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE DUODENUM AND PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, 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 18207666 ↗
• MalfunctionJun 14, 2023Break; Defective Device; Break; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TRUETOME JAG 44 WAS ALREADY DEFORMED DURING THE INSERTION THROUGH THE SCOPE. WHEN TRYING TO CANNULATE THE PAPILLA, THE CUTTING WIRE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126478 ↗
• MalfunctionNov 21, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN TRUETOME JAG 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE NURSE TRIED TO STRAIN THE TRUETOME JAG 44; HOWEVER, THE CUTTING WIRE BROKE AT ONCE. 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 15838156 ↗
• MalfunctionJan 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AFTER THE PHYSICIAN INSERTED THE JAGWIRE GUIDEWIRE INTO THE CBD, THE TRUETOME WAS CONNECTED TO THE GENERATOR FOR SPHINCTEROTOMY. HOWEVER, DURING SPHINCTEROTOMY, THE CUTTING WIRE WAS BROKEN. IT WAS REPORTED THAT THE WIRE ANCHOR HAD DISLODGED FROM THE CATHETER. ADDITIONALLY, NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PHYSICIAN REMOVED THE DEVICE AND 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 13308854 ↗
• MalfunctionOct 27, 2021Break; Defective Device; Break; Defective Device

  INITIALLY IT WAS REPORTED THAT THERE WAS AN UNKNOWN EVENT WITH A TRUETOME JAG 44 DEVICE ON AN UNKNOWN DATE. THE DEVICE WAS RETURNED, AND PRELIMINARY INVESTIGATION RESULTS REVEALED THAT THERE IS A BREAK IN THE CUTTING WIRE. THIS EVENT HAS NOW BEEN DEEMED REPORTABLE AND FULL INVESTIGATION RESULTS WILL FOLLOW IN A FINAL REPORT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705002 ↗
• MalfunctionJun 22, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE DUODENUM AND PAPILLA DURING A CATHETERIZATION OF THE BILIARY DUCT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME JAG 44 BROKE AT THE END OF THE SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWS THE CUTTING WIRE BROKEN AND KINKED/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043017 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, AN INITIAL CUT OF THE PAPILLA WAS MADE. THE ACTIVATION OF THE CUTTING WIRE WAS STOPPED AS THE DEVICE WAS BEING REPOSITIONED IN PREPARATION FOR THE SECOND CUT; HOWEVER, IT WAS NOTICED THAT THE CUTTING WIRE BROKE AT THIS TIME. 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 11816085 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ATTEMPTING TO CUT THE PAPILLA, THE CUTTING WIRE BROKE. REPORTEDLY, THE EXPOSED CUTTING WIRE HAD FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED. ADDITIONALLY, 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 STABLE. NOTE: A PHOTO OF THE COMPLAINT DEVICE PROVIDED BY THE COMPLAINANT SHOWS THE DEVICE OUTSIDE THE PATIENT WITH THE CUTTING WIRE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11217847 ↗
• MalfunctionOct 15, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE DUODENUM 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 INSERTED THE SPHINCTEROTOME AND WANTED TO CUT THE PAPILLA. 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 10684778 ↗
• MalfunctionJan 7, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE SPHINCTER OF ODDI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE ELECTRIC CURRENT WAS ACTIVATED THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE 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; No Consequences Or Impact To Patient

  MAUDE report 9561786 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE SPHINCTER OF ODDI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS ACTIVATED, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND TRUETOME JAG 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9214448 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN PRESSED THE PEDAL TO ACTIVATE THE ELECTRIC CURRENT, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND TRUETOME JAG 44, USING THE SAME GENERATOR AND ACTIVE CORD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198178 ↗
• MalfunctionSep 24, 2019Break; Break

  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 PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUTTING WIRE BROKE DURING AN ATTEMPT TO CUT THE PAPILLA. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND TRUETOME JAG 44, USING THE SAME GENERATOR AND ACTIVE CORD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE END OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9110848 ↗
• MalfunctionSep 24, 2019Break; Break

  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 PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUTTING WIRE BROKE DURING AN ATTEMPT TO CUT THE PAPILLA. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND TRUETOME JAG 44, USING THE SAME GENERATOR AND ACTIVE CORD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE END OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9110275 ↗
• MalfunctionNov 6, 2018Break; Break

  IT WAS REPORTED THAT TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND TRUETOME JAG 44, USING THE SAME GENERATOR AND ACTIVE CORD. 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 8044606 ↗
• MalfunctionOct 2, 2018Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE MAIN PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. THE PHYSICIAN WAS UNABLE TO REMOVE THE TRUETOME 44 FROM THE ENDOSCOPE AND SO HE HAD TO REMOVE THE ENDOSCOPE ALONG WITH THE TRUETOME 44. THE PROCEDURE WAS COMPLETED WITH A SECOND TRUETOME 44 TO COMPLETE THE PROCEDURE, USING THE SAME GENERATOR. THERE WERE NO USER INJURIES NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928578 ↗
• MalfunctionMay 8, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME¿ JAG 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE DOING THE SPHINCTEROTOMY, THE CUT WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL GENERATOR AND ACTIVE CORD USING A SECOND 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 Consequences Or Impact To Patient

  MAUDE report 7495877 ↗
• MalfunctionDec 19, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME¿ JAG 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) EXAMINATION DURING SPHINCTEROTOMY (ES) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE BROKE. BECAUSE THE CUT WIRE WAS BROKEN, IT WAS NOT POSSIBLE TO REMOVE THE TRUETOME FROM THE DUODENOSCOPE. THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENT IN ORDER TO REMOVE THE TRUETOME FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A SECOND TRUETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7131586 ↗
• MalfunctionDec 19, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN A PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TRUETOME 44 CUTTING WIRE BROKE. REPORTEDLY, IT WAS DIFFICULT TO REMOVE THE TRUETOME 44 FROM THE WORKING CHANNEL OF THE ENDOSCOPE, SO THEY DECIDED TO REMOVE THE ENDOSCOPE AND THE TRUETOME 44 TOGETHER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAS BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130138 ↗
• MalfunctionOct 20, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME¿ JAG 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE BROKE. NO PART OF THE DEVICE DETACHED AND FELL INSIDE 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6964632 ↗