Autotome™ RX 49 M00545150Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 08714729415138), received between Apr 16, 2018 and Dec 18, 2025 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SPHINCTEROTOMY WIRE BROKE. IT WAS REPORTED THAT THE DEVICE WAS COMPLETELY AND IMMEDIATELY REMOVED FROM 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 23839685 ↗
• MalfunctionOct 15, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 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, AN ADVANCEMENT OF THE ENDOSCOPE WAS SMOOTH, AND CANNULATION WAS SUCCESSFUL. CHOLANGIOGRAPHY WAS PERFORMED, BUT DURING THE PROCESS OF FORMING THE BOW, THE CUTTING WIRE WAS FRACTURE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT WHERE IT CAN BE OBSERVED 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 49. 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 23287599 ↗
• MalfunctionMay 23, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CHOLEDOCHOGRAPHY WAS PERFORMED AFTER SUCCESSFUL INSERTION OF THE ENDOSCOPE AND INTUBATION. UPON BOWING THE DEVICE, THE CUTTING WIRE OF THE AUTOTOME RX 49 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 AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THE IMAGING PHOTO INSIDE THE PATIENT SHOWS THAT THE CUTTING WIRE WAS BROKEN. A PHOTO OF THE DEVICE OUTSIDE THE PATIENT ALSO SHOWS THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076052 ↗
• MalfunctionMay 16, 2025Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS ATTEMPTED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT AFTER THE DEVICE ENTERED THE PATIENT, THE AUTOTOME RX 49 DID BOW CORRECTLY BUT WOULD NOT RELEASE THE BOW. 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 22037962 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN AUTOTOME RX 49 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 20685066 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN AUTOTOME RX 49 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 20684909 ↗
• MalfunctionJul 15, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AUTOTOME RX 49 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH CHOLEDOCHOLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE CUTTING THE PAPILLA, THE CUTTING WIRE SUDDENLY GOT FRACTURED. 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19737885 ↗
• MalfunctionJul 11, 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 AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE INCISION OF THE PAPILLA WAS PERFORMED, THE CUTTING WIRE SEPARATED. 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 19718481 ↗
• MalfunctionMay 17, 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 AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE RX 49 BROKE OFF AFTER STEPPING ON THE FOOT PEDAL SEVERAL TIMES DURING AN ATTEMPT TO PERFORM A PAPILLOTOMY. 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 19338475 ↗
• MalfunctionApr 1, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DISTAL BILE DUCT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 49 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 19016341 ↗
• MalfunctionFeb 22, 2024Break; Use of Device Problem; Material Deformation; Break; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE RX 49 BROKE WHILE PERFORMING DUODENAL SPHINCTEROTOMY. 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: IT WAS REPORTED THAT THE DEVICE ENERGIZED PRIOR TO BOWING; HOWEVER, PER THE INSTRUCTIONS FOR USE (IFU), "PRECAUTION: THE SPHINCTEROTOME DOES NOT NEED TO BE ENERGIZED PRIOR TO PERFORMING SPHINCTEROTOMY. ENERGIZING THE CUTTING WIRE PRIOR TO USE WILL CAUSE PREMATURE CUTTING WIRE FATIGUE AND WILL COMPROMISE THE CUTTING WIRE'S INTEGRITY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757578 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE SPHINCTER OF ODDI AND BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PULL WIRE AT THE HANDLE OF THE AUTOTOME RX 49 BROKE AND IT COULD NOT BE BOWED AND COULD NOT CUT. THE DEVICE WAS REMOVED FROM THE PATIENT, AND WHEN IT WAS TESTED, STILL IT COULD NOT BE BOWED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE PULL WIRE AT THE HANDLE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120418 ↗
• MalfunctionOct 27, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 49 WAS DEFORMED AS IT GOT KINKED, MAKING IT IMPOSSIBLE TO CONTINUE THE PROCEDURE. 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 WAS BROKEN. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18024271 ↗
• MalfunctionOct 24, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CUTTING WIRE WAS INSERTED, THE DEVICE WAS THEN BOWED. WHEN THE DEVICE WAS ENERGIZED, THE CUTTING WIRE OF THE AUTOTOME RX 49 "FRACTURED" AND IT COULD NOT CUT. 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 17996251 ↗
• MalfunctionOct 19, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE PAPILLA AREA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, UPON PAPILLA INCISION, WHEN THE DEVICE WAS ENERGIZED FOR THE SECOND TIME, THE CUTTING WIRE OF THE AUTOTOME RX 49 GOT DAMAGED AND SEPARATED. 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 17967268 ↗
• MalfunctionApr 21, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6)2023. DURING THE PROCEDURE, THE NURSE HAD DIFFICULTY ADVANCING THE AUTOTOME RX 49. DURING THE DELIVERY, THE WIRE IN THE MIDDLE OF THE HANDLE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787357 ↗
• MalfunctionMar 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE PAPILLA DURING A NORMAL DUODENAL PAPILLARY INCISION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CUTTING WIRE OF SPHINCTEROTOME WAS DAMAGED. IT WAS REPORTED THAT THE WIRE ANCHOR WAS DISLODGED, AND 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 16593157 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, "THE PROCEDURE COULD NOT BE PERFORMED DUE TO THE CUTTING WIRE 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073491 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, "THE PROCEDURE COULD NOT BE PERFORMED DUE TO THE CUTTING WIRE 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073486 ↗
• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, "THE PROCEDURE COULD NOT BE PERFORMED DUE TO THE CUTTING WIRE 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073325 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 49 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. 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 15152465 ↗
• MalfunctionFeb 2, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS INTENDED TO BE USED IN THE COMMON BILE DUCT IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING UNPACKING OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE CUTTING WIRE OF THE AUTOTOME RX 49 WAS BROKEN. 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 13427431 ↗
• MalfunctionFeb 2, 2022Break; Failure to Fold; Material Deformation; Break; Failure to Fold; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE DEVICE DID NOT BOW. THE PROCEDURE WAS COMPLETED 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 RESULTS: THE CUTTING WIRE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424068 ↗
• MalfunctionJul 20, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 49 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. 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 12199864 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON APRIL 2, 2021. DURING THE PROCEDURE, AFTER APPLYING CURRENT TO THE AUTOTOME RX 49, WHEN THE PHYSICIAN TRIED TO BOW THE DEVICE AGAIN, IT WAS NOTICED THAT THE CUTTING WIRE BROKE. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700518 ↗