Jagtome RX 44 M00573040Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729776659), received between Aug 29, 2018 and Feb 9, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Break” (36 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-0773-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING PROCEDURE, A JAGTOME RX 44 WAS USED TO CUT THE AMPULLA OF THE PATIENT. WHILE PERFORMING THE SPHINCTEROTOMY, THE CUTTING WIRE SNAPPED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. 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 24292892 ↗
• 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. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE WAS CUT DURING SPHINCTEROTOMY. THE SAME PROBLEM OCCURRED WITH THE TRUETOME JAG 44. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081900 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN IN POSITION TO PERFORM SPHINCTEROTOMY, CUTTING WAS NOT WORKING. AFTER TROUBLESHOOTING, IT WAS DISCOVERED THAT THE CUT WIRE OF THE TOME BROKE AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME 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 21138921 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER PERFORMING THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE OFF OF THE TOME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: A PHOTO OF THE COMPLAINT DEVICE INSIDE THE PATIENT FROM THE MONITOR WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800179 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN CAUTERY WAS APPLIED, THE CUTTING WIRE OF JAGTOME 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 18884049 ↗
• MalfunctionJan 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN JAGTOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHILE PERFORMING SPHINCTEROTOMY WITH DIATHERMIA, THE WIRE ANCHOR OF THE JAGTOME RX 44 GOT DISLODGED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. 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 18541475 ↗
• MalfunctionDec 12, 2022Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2022: IT WAS REPORTED THAT THE WIRE ANCHOR WAS DISLODGED, AND NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15963101 ↗
• MalfunctionFeb 9, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE DEVICE WAS REMOVED FROM THE PACKAGE AND INSERTED THROUGH THE SCOPE. IT WAS THEN NOTICED THAT THERE WAS NO CUTTING WIRE PRESENT; HENCE, THEY COULD NOT USE THE DEVICE TO BOW OR CUT. THE DEVICE WAS REMOVED AND 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 13497851 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE BILIARY DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE WHEN THEY FIRST BOWED THE DEVICE. 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 13168623 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE WHEN THEY FIRST BOWED THE DEVICE. 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 13168578 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE WHICH MADE THE DEVICE UNABLE TO BOW COMPLETELY. 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 13112165 ↗
• MalfunctionNov 29, 2021Break; Break

  BOSTON SCIENTIFIC RECEIVED A JAGTOME RX 44 DEVICE WITH NO ASSOCIATED INFORMATION. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: BROKEN CUTTING WIRE. PLEASE SEE FULL INVESTIGATION RESULTS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885316 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, WHEN THEY PERFORMED SPHINCTEROTOMY, DURING THE FIRST USE OF JAGTOME RX 44, IT WAS NOTICED THAT 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 12123202 ↗
• MalfunctionJun 30, 2021Break; Failure to Conduct; Defective Device; Material Deformation; Break; Failure to Conduct; Defective Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THE JAGTOME RX 44 COULD NOT BE ENERGIZED TO PERFORM SPHINCTEROTOMY. THE DEVICE WAS ROTATED ELEVEN TIMES COUNTER CLOCKWISE AND WAS SET BACK TO NEUTRAL ORIENTATION; HOWEVER, STILL THEY COULD NOT ENERGIZE THE DEVICE. THEY ALSO EVEN TRIED TO BOW AND RECONNECT THE DEVICE BUT NOTHING HAPPENED. IT WAS REPORTED THAT THE MIDDLE OF THE CUTTING WIRE BLACKENED. THE PROCEDURE WAS COMPLETED ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092667 ↗
• MalfunctionJun 25, 2021Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE BILIARY SYSTEM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHEN THEY BOWED THE DEVICE, IT DID NOT BOW AS THE CUTTING WIRE OF THE JAGTOME 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 12068463 ↗
• MalfunctionJun 3, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE JAGTOME RX 44 WAS ABLE TO CUT WELL INITIALLY. WHEN THEY TRIED TO EXTEND TO PERFORM SPHINCTEROTOMY, THE CUTTING WIRE SNAPPED FROM THE BACK PART OF THE TOME. 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 11931579 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE SPHINCTER OF ODDI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE CUTTING WIRE FROM THE TIP OF THE DEVICE BROKE BUT THE PROXIMAL PORTION OF THE CUTTING WIRE WAS STILL ATTACHED. 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 11815801 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHILE CURRENT WAS APPLIED AS AN ATTEMPT TO PERFORM SPHINCTEROTOMY, THE CUTTING WIRE OF JAGTOME RX 44 BROKE. IT WAS REPORTED THAT A GROUNDING PAD WAS USED. 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 11739229 ↗
• MalfunctionFeb 4, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE AMPULLA DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE COMPLETING THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE. REPORTEDLY, CURRENT WAS APPLIED WHEN THE CUTTING WIRE BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279594 ↗
• MalfunctionDec 11, 2020Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) AND AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE UPON BOWING. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10991851 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME 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, AFTER ROTATING AND MANIPULATING THE TOME DURING THE PROCEDURE, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE DETACHED AND FELL INTO THE PATIENT. DURING REMOVAL OF THE DEVICE FROM THE ENDOSCOPE THE PHYSICIAN WAS PRICKED IN THE FINGER BY THE BROKEN CUTTING WIRE. THE AFFECTED AREA WAS IRRIGATED, THE PATIENT WAS TESTED FOR COMMUNICABLE DISEASES AND FACILITY PROTOCOLS WERE FOLLOWED. THE PATIENT DOES NOT HAVE ANY KNOWN COMMUNICABLE DISEASES AND THE PHYSICIAN WAS WEARING GLOVES AT THE TIME OF THE INCIDENT. REPORTEDLY, THE PHYSICIAN HAS NO FURTHER CONCERNS REGARDING THIS NEEDLE STICK EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 10898727 ↗
• MalfunctionSep 25, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 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, WHEN THE TOME WAS PASSED DOWN THE SCOPE IT COME OUT WITH AN INCORRECT ORIENTATION. ALSO, THE ORIENTATION OF THE CUTTING WIRE WAS INCORRECT WITH RESPECT TO THE PLASTIC 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 Consequences Or Impact To Patient

  MAUDE report 10586325 ↗
• MalfunctionSep 17, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME 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 ORIENTATION OF THE CUTTING WIRE AND THE CATHETER TIP WAS INCORRECT WHEN THE DEVICE EXITED THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION ON 15OCT2020. REPORTEDLY, THE PHYSICIAN "RIPPED THE DEVICE OUT" WITH THE WIRE STILL LOCKED WHICH MAY HAVE CAUSED SOME EXCESS DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10549993 ↗
• MalfunctionAug 24, 2020Break; Break

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO JAGTOME RX 44 DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE MAJOR DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY TRIED TO CUT THE PAPILLA THE CUTTING WIRE BROKE. THE DEVICE WAS SLIGHTLY TENSED BUT CURRENT WAS NOT APPLIED. A SECOND JAGTOME WAS USED; HOWEVER, THE CUTTING WIRE WAS ALSO BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIRD JAGTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442353 ↗
• MalfunctionAug 24, 2020Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO JAGTOME RX 44 DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE MAJOR DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY TRIED TO CUT THE PAPILLA THE CUTTING WIRE BROKE. THE DEVICE WAS SLIGHTLY TENSED BUT CURRENT WAS NOT APPLIED. A SECOND JAGTOME WAS USED; HOWEVER, THE CUTTING WIRE WAS ALSO BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIRD JAGTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442352 ↗