Autotome™ RX 39 M00545190Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 08714729444763), received between Apr 11, 2017 and May 5, 2026 — classified as 3 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (50 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY DISEASE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE WHEN SPHINCTEROTOMY WAS PERFORMED. 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. 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 CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085394 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY DISEASE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE WHEN SPHINCTEROTOMY WAS PERFORMED. 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. 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 CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085388 ↗
• MalfunctionMay 4, 2026Use of Device Problem; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUT WIRE WAS BENT AND DIFFICULT TO CANNULATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE TIP LOOKED DEFORMED DURING EVALUATION UPON RECEIPT HOWEVER THE DEVICE WAS STILL USED. PER THE INSTRUCTION FOR USE (IFU), DO NOT USE THE DEVICE IF ANY DEFECT, MALFUNCTION, OR ABNORMALITY IS OBSERVED DURING INSPECTION, AS THIS MAY RESULT IN PATIENT INJURY OR DEVICE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071923 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLANGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUT WIRE BROKE OFF FROM THE TIP OF THE TOME. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038307 ↗
• MalfunctionApr 25, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUT WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 24991740 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT PRIMARY SCLEROSING CHOLANGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A SPHINCTEROTOMY WAS PERFORMED. AT THE COMPLETION OF THE CUT, THE PROXIMAL END OF THE EXPOSED CUTTING WIRE SNAPPED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. A PHOTO OF AN UNKNOWN DEVICE WAS PROVIDED AND SHOWED A BROKEN WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841022 ↗
• MalfunctionMar 30, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN MAKING THE SPHINCTEROTOMY. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716187 ↗
• MalfunctionMar 23, 2026Deformation Due to Compressive Stress; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, IT WAS REPORTED THAT THE DEVICE CAME OUT OF THE PACKAGE TWISTED. 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 FULLY RECOVERED. 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 24665079 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN ENERGIZED WITH CAUTERY. 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 24479057 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. PRIOR TO THE PROCEDURE, PHYSICIAN WENT TO BEGIN SPHINCTEROTOMY AND ENERGY WAS NOT BEING DELIVERED. UPON BOWING AND UNBOWING, THE PHYSICIAN REALIZED THAT THE CUT WIRE WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401790 ↗
• MalfunctionJan 9, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023233 ↗
• MalfunctionOct 31, 2025Peeled/Delaminated; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE AMPULLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE TOME WAS TORN, AND THE PAINT WAS PEELED OFF THE EXTRUSION. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT. 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 23441612 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE DUODENUM OR AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN BOWING THE SPHINCTEROTOME 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 AUTOTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352208 ↗
• MalfunctionOct 17, 2025Break; Failure to Align; Break; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTME RX 39 WAS ATTEMPTED TO BE USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WAS BROKEN, AND THE TIP WOULD NOT RELAX WHEN BOW WAS DOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320212 ↗
• MalfunctionSep 29, 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 AUTOTOME RX 39 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE PRIOR TO SPHINCTEROTOMY. 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 23174759 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHILE PERFORMING SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853465 ↗
• MalfunctionAug 18, 2025Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO AUTOTOME RX 39 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING A PAPILLOTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, AFTER ROTATING THE AUTOTOME, THE WIRE DID NOT FACE THE INTENDED POSITION. THE SAME PROBLEM OCCURRED WITH A SECOND AUTOTOME. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836252 ↗
• MalfunctionAug 18, 2025Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO AUTOTOME RX 39 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING A PAPILLOTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, AFTER ROTATING THE AUTOTOME, THE WIRE DID NOT FACE THE INTENDED POSITION. THE SAME PROBLEM OCCURRED WITH A SECOND AUTOTOME. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836231 ↗
• MalfunctionAug 4, 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 AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE BILIARY AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE BROKE DURING SPHINCTEROTOMY. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE CUTTING WIRE WAS BROKEN AND KINKED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709261 ↗
• InjuryJul 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 AN AUTOTOME RX 39 WAS USED IN THE DUODENUM AND COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING SPHINCTEROTOMY, THE TECH BOWED THE TOME SLIGHTLY AND THE CUT WIRE POPPED OFF THE CATHETER. THE DETACHED CUT WIRE WAS SUCCESSFULLY RETRIEVED USING A NET. 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 22399143 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, A DOUBLE WIRE CANNULATION WAS PERFORMED. WHEN THE CUTTING WIRE CAME IN CONTACT WITH THE GUIDEWIRE IN THE PANCREATIC DUCT, THE CUTTING WIRE OF THE AUTOTOME RX 39 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 21529982 ↗
• MalfunctionSep 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTICED THAT THE CANNULATION WAS DIFFICULT. THE PATIENT HAD A NARROW DUCT, AND A PANCREATIC DUCT STENT WAS IN PLACE WITHIN THE DUCT. THE WIRE ANCHOR DISLODGED FROM THE CATHETER BUT THE CUTTING WIRE WAS INTACT. NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER AUTOTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20298736 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS BEING PREPARED FOR USE IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION OUTSIDE THE PATIENT, UPON OPENING THE PACKAGE, IT WAS NOTICED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085560 ↗
• MalfunctionAug 23, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED, TO BOSTON SCIENTIFIC CORPORATION. THAT AN AUTOTOME RX 39 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 COULD NOT ADVANCE INSIDE THE DEVICE. IT WAS REPORTED, THAT A FOREIGN OBJECT OR SUBSTANCE WAS INSIDE THE GUIDEWIRE PORT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39 DEVICE. THERE WERE NO PATENT COMPLICATIONS REPORTED, AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE, OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER. AND A BROWN COLORED FOREIGN SUBSTANCE CAN BE SEEN INSIDE THE WORKING LENGTH OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049867 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS BEING PREPARED FOR USE IN THE DUODENUM AND BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE DEVICE WAS BROKEN AS THE WIRE APPEARED TO BE CUT AND LOOSE. 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 20020515 ↗