Jagtome RX 44 M00573060Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729776673), received between Feb 20, 2018 and Jun 29, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (16 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-0775-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Break; Use of Device Problem; Material Twisted/Bent

  It was reported to Boston Scientific Corporation that a Jagtome RX 44 was attempted to be used in the common duct during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat stones in the common duct performed on (b)(6) 2026.During the procedure. the cutting wire came out of the packaging twisted, and when turned the sphincterotome to perform sphincterotomy, the cutting wire snapped. It was reported that no part of the cutting wire was detached and fell into the patient. A second Jagtome RX 44 was attempted to be used; however, the cutting wire was completely twisted. They did not introduce it in the patient and discarded it immediately. The procedure was completed with a third Jagtome RX 44. There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.Note: It was reported that the cutting wire came out of the packaging twisted; however, per the Instructions for Use (IFU), Precaution: Kinks in the catheter will hinder injection capability. Do not use the Sphincterotome if any defect is found during inspection.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661255 ↗
• MalfunctionApr 30, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. A PHOTO WAS PROVIDED FROM THE CUSTOMER SHOWING THAT THE CUTTING WIRE WAS INTACT AND THE WIRE ANCHOR WAS DISLODGED. 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 25038800 ↗
• MalfunctionMay 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 A JAGTOME RX 44 WAS USED IN THE DUODENUM IN FRONT OF THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE DURING CUTTING. 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 22015387 ↗
• MalfunctionMar 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 A JAGTOME RX 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE AFTER ENERGIZING THE THIRD TIME. THE DEVICE WAS APPROXIMATELY TENSED FOR ABOUT ONE THIRD. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED 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 21691953 ↗
• MalfunctionDec 27, 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 JAGTOME RX 44 WAS USED IN THE PAPILLA VATERI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN STARTED TO CUT THE PAPILLA, AND THE CUTTING WIRE BROKE IMMEDIATELY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029079 ↗
• MalfunctionSep 9, 2024Break; Device Slipped; Adverse Event Without Identified Device or Use Problem; Break; Device Slipped; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6)2024. DURING PREPARATION, THE DEVICE WAS UNPACKED, AND IT WAS NOTICED THAT THE GUIDEWIRE WAS IN THE MIDDLE OF THE TOME, AND OUT OF THE GUIDEWIRE CHANNEL. THE GUIDEWIRE WAS PUT BACK INTO THE CHANNEL AND THE TOME WORKED AS INTENDED BUT IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE DEVICE WAS RETURNED, AND A DEVICE ANALYSIS REVEALED THE CUTTING WIRE OF THE DEVICE WAS BLACKENED, KINKED AND BROKEN FROM THE PROXIMAL PIERCE HOLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF CUTTING WIRE BREAK. PLEASE SEE DEVICE ANALYSIS RESULTS FOR FULL INVESTIGATION DETAILS. 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 BROKEN. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169692 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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, THE PHYSICIAN ENTERED THE PAPILLA WITH THE DEVICE, THE NURSE BOWED THE DEVICE AND THE PHYSICIAN ADDED ENERGY FROM THE GENERATOR. IT WAS REPORTED THAT BLEEDING WAS IMMEDIATE AFTER SPHINCTEROTOMY, RESULTING IN HEAVY BLEEDING AND HEMATOMA. THE PROCEDURE WAS ABLE TO BE COMPLETED USING THE ORIGINAL JAGTOME RX 44 DEVICE. THE PATIENT HAD HEAVY BLEEDING AND HEMATOMA. A METAL STENT WAS PLACED TO STOP THE BLEEDING AND THE PATIENT WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19912242 ↗
• MalfunctionJun 28, 2024Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE SPHINCTER OF ODDI BILIARY TRACT DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE JAGTOME WAS REMOVED FROM THE DUODENOSCOPE, IT WAS OBSERVED THAT THE CUTTING WIRE WAS DISTENDED. 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 19630864 ↗
• MalfunctionJun 3, 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 JAGTOME RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE BENT AND BROKE THE LAST 5CM OFF. IT WAS REPORTED THAT NO PART OF THE DETACHED GUIDEWIRE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454056 ↗
• MalfunctionNov 1, 2022Break; Failure to Fold; Material Twisted/Bent; Break; Failure to Fold; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS INTENDED TO BE USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2022. DURING PREPARATION, THE NURSE NOTICED THAT THE DEVICE WOULD NOT COMPLETELY BOW AND THE CUTTING WIRE OF THE JAGTOME RX 44 WAS NOT ATTACHED. IT WAS FURTHER CLARIFIED THAT THE CUTTING WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THERE WAS A PHOTO PROVIDED BY THE CUSTOMER SHOWING ONLY THE DISTAL END OF THE DEVICE WITH THE CUTTING WIRE INTACT BUT TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709916 ↗
• InjurySep 29, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE BILE DUCT DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE TOME WAS BOWED, 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. THE PATIENT HAD BLEEDING AND HEMATOMA AND A FULL COVER METAL STENT WAS PLACED TO STOP THE BLEEDING. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 5, 2022: PLACING A SELF-EXPANDING METAL STENT WAS NOT PLANNED FOR THIS PROCEDURE. IT WAS PLACED BECAUSE OF THE BLEEDING. IT WAS REPORTED THAT THERE IS A PLAN OF REMOVING THE STENT.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15501377 ↗
• MalfunctionNov 30, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THEY WERE TRYING TO CUT THE PAPILLA OF VATER, "THE CUTTING WIRE TORN OUT." IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. ADDITIONALLY, THE DUODENOSCOPE WAS NOT DAMAGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPETED USING 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 DOING WELL. 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 12897198 ↗
• MalfunctionAug 26, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE PAPILLA AND BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AS SPHINCTEROTOMY WAS PERFORMED, THE CUTTING WIRE SEVERED FROM THE CENTER. IT WAS REPORTED THAT THERE WAS A RISK OF PIERCING THE ENDOSCOPE CHANNEL WHEN THE JAGTOME RX 44 WAS REMOVED. ADDITIONALLY, NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NOTE: IMAGES FROM THE PROCEDURE WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN NEAR THE PROXIMAL PIERCE HOLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369881 ↗
• MalfunctionFeb 18, 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. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY USED THE PRELOADED GUIDEWIRE TO CANNULATE THE AMPULLA. AS THEY WERE ABOUT TO USE THE CUTTING WIRE, THE CUTTING WIRE BROKE. NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. REPORTEDLY, THE DEVICE WAS NOT ENERGIZED PRIOR TO BOWING AND WHEN NOT IN CONTACT WITH THE TISSUE. ALSO, THE EXPOSED CUTTING WIRE HAD FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED. 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 11344138 ↗
• MalfunctionJan 27, 2021Break; Break

  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 PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THEY EXITED THE PAPILLA AND WHEN THE DEVICE WAS IN RELAXED POSITION, THE CUTTING WIRE BROKE FROM THE END OF THE CATHETER. NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. REPORTEDLY, THE DEVICE WAS NOT ENERGIZED PRIOR TO BOWING AND WHEN NOT IN CONTACT WITH THE TISSUE. ALSO, THE EXPOSED CUTTING WIRE HAD FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED. 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 11239279 ↗
• MalfunctionJun 18, 2020Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS IN THE PAPILLA DUODENI VATERI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME WAS UNABLE TO BOW. 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: CUTTING WIRE DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171471 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OUTSIDE THA PATIENT, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530395 ↗
• MalfunctionMay 3, 2019Break; 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) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE CUTTING WIRE WAS NOTICED TO BE SEPARATED FROM THE CANNULA. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8578907 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A JAGTOME RX 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE JAGTOME RX 44 COULD EASILY BE INSERTED THROUGH THE WORKING CHANNEL OF THE OLYMPUS DUODENOSCOPE. AS THE PHYSICIAN TENSED THE PAPILLA OF THE RX 44 PAPILLOTOME FOR CUTTING, THE CUTTING WIRE TORE FROM THE FIXATION. A CUTTING OF THE PAPILLA WAS THUS NO LONGER POSSIBLE. SINCE THE PAPILLOTOME COULD NO LONGER BE REMOVED FROM THE WORKING CHANNEL, THE DOCTOR HAD TO REMOVE THE DUODENOSCOPE TOGETHER WITH THE PAPILLOTOME FROM THE PATIENT. TO BE ABLE TO REMOVE THE PAPILLOTOME FROM THE WORKING CHANNEL, IT HAD TO BE CUT APART WITH A PAIR OF PLIERS. THE PHYSICIAN COULD THEN FINISH THE PROCEDURE WITH ANOTHER IDENTICAL PRODUCT. THERE WERE NO INJURY NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256392 ↗
• MalfunctionFeb 20, 2018Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-00473 FOR THE FIRST JAGTOME¿ RX 44, 3005099803-2018-00474 FOR THE SECOND JAGTOME¿ RX 44, AND 3005099803-2018-00475 FOR THE THIRD JAGTOME¿ RX 44. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE JAGTOME¿ RX 44 DEVICES WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUT WIRE WAS ORIENTED IN THE WRONG DIRECTION WHEN IT FIRST EXITED THE SCOPE. TWO MORE JAGTOME¿ RX 44 DEVICES WERE USED DURING THE PROCEDURE AND SAME THING HAPPENED. REPORTEDLY, THERE WAS NO ANY VISIBLE DAMAGE TO THESE DEVICES PRIOR TO PUTTING IT THROUGH THE SCOPE OR AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH JAGTOME¿ 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 7284679 ↗
• MalfunctionFeb 20, 2018Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-00473 FOR THE FIRST JAGTOME¿ RX 44, 3005099803-2018-00474 FOR THE SECOND JAGTOME¿ RX 44, AND 3005099803-2018-00475 FOR THE THIRD JAGTOME¿ RX 44. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE JAGTOME¿ RX 44 DEVICES WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUT WIRE WAS ORIENTED IN THE WRONG DIRECTION WHEN IT FIRST EXITED THE SCOPE. TWO MORE JAGTOME¿ RX 44 DEVICES WERE USED DURING THE PROCEDURE AND SAME THING HAPPENED. REPORTEDLY, THERE WAS NO ANY VISIBLE DAMAGE TO THESE DEVICES PRIOR TO PUTTING IT THROUGH THE SCOPE OR AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH JAGTOME¿ 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 7284678 ↗
• MalfunctionFeb 20, 2018Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-00473 FOR THE FIRST JAGTOME¿ RX 44, 3005099803-2018-00474 FOR THE SECOND JAGTOME¿ RX 44, AND 3005099803-2018-00475 FOR THE THIRD JAGTOME¿ RX 44. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE JAGTOME¿ RX 44 DEVICES WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUT WIRE WAS ORIENTED IN THE WRONG DIRECTION WHEN IT FIRST EXITED THE SCOPE. TWO MORE JAGTOME¿ RX 44 DEVICES WERE USED DURING THE PROCEDURE AND SAME THING HAPPENED. REPORTEDLY, THERE WAS NO ANY VISIBLE DAMAGE TO THESE DEVICES PRIOR TO PUTTING IT THROUGH THE SCOPE OR AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH JAGTOME¿ 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 7284672 ↗