Ultratome XL M00535920Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 08714729103318), received between Feb 20, 2018 and Sep 30, 2026 — classified as 2 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Break” (86 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 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953998 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951035 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951030 ↗
• MalfunctionApr 29, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER DURING DISSECTION OF THE COMMON BILE DUCT 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 AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038137 ↗
• MalfunctionDec 9, 2025Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN CUTTING THE AMPULLA, THE CUTTING WIRE OF THE ULTRATOME XL 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. NOTE: IT WAS REPORTED THAT THE DEVICE WAS ENERGIZED PRIOR TO BOWING.; HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), 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 23764005 ↗
• MalfunctionNov 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 AN ULTRATOME XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN PRELOADED AN ULTRATOME XL 30 MM CUTTING WIRE WITH A JAGWIRE 0.035"/450 CM AND INSERTED IT THROUGH THE WORKING CHANNEL OF THE DUODENOSCOPE. SPHINCTEROTOMY WAS THEN PERFORMED USING ELECTROCAUTERY VIA THE ERBE MACHINE, APPLIED THROUGH THE CUTTING WIRE OF THE ULTRATOME. HOWEVER, APPROXIMATELY TWO MINUTES INTO THE PROCEDURE, THE CUTTING WIRE FRACTURED, LEADING TO DISCONTINUATION OF ITS USE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507050 ↗
• MalfunctionNov 7, 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 ULTRATOME XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN PRELOADED AN ULTRATOME XL 30 MM CUTTING WIRE WITH A JAGWIRE 0.035"/450 CM AND INSERTED IT THROUGH THE WORKING CHANNEL OF THE DUODENOSCOPE. SPHINCTEROTOMY WAS THEN PERFORMED USING ELECTROCAUTERY VIA THE ERBE MACHINE, APPLIED THROUGH THE CUTTING WIRE OF THE ULTRATOME. HOWEVER, APPROXIMATELY TWO MINUTES INTO THE PROCEDURE, THE CUTTING WIRE FRACTURED, LEADING TO DISCONTINUATION OF ITS USE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501465 ↗
• MalfunctionOct 22, 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 ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, BEFORE INSERTING THE DEVICE INTO THE PATIENT, AN OPENING AND CLOSING TEST HAD BEEN PERFORMED WITHOUT ANY DIFFICULTY, VERIFYING THE DEVICE FUNCTIONALITY AND INTEGRITY. HOWEVER, DURING ERCP THE CUTTING WIRE BROKE. 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 ULTRATOME XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364398 ↗
• MalfunctionJul 15, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING PREPARATION OUTSIDE THE PATIENT, WHEN THE DEVICE WAS UNPACKED, SALINE WAS INJECTED NORMALLY BUT IT WAS NOTICED THAT THE CUTTING WIRE WAS BENT. 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 22508432 ↗
• MalfunctionJun 16, 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 ULTRATOME XL WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS WITH ACUTE CHOLANGITIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE DEVICE WAS ENERGIZED, THE CUTTING WIRE OF THE ULTRATOME XL BROKE. 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 22212044 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN CUTTING THE AMPULLA AND STEPPING ON THE CAUTERY MACHINE, THE CUTTING WIRE SUDDENLY BROKE. IT WAS REPORTED THAT NO PART 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 AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135771 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS PASSED THROUGH THE WORKING CHANNEL, THE PATIENT WAS CANNULATED AND THE SPHINCTEROTOMY WAS PERFORMED. WHEN OPENING WITH A LARGER ARCH, THE CUTTING WIRE BROKE. A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THAT THE CUTTING WIRE WAS BROKEN. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069087 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. 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 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 21885585 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. 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 ULTRATOME XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868667 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE SPHINCTEROTOMY WAS STARTED WITH LITTLE ANGULATION OF THE PAPILLOTOMY AND UPON CUTTING, THE WIRE BURST. IT WAS REPORTED THAT NOTHING WAS LEFT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21573180 ↗
• MalfunctionMar 5, 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 ULTRATOME XL WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL. 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 21530642 ↗
• MalfunctionJan 31, 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 ULTRATOME XL WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE IN THE HANDLE PART BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL. 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 21284899 ↗
• MalfunctionDec 31, 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 ULTRATOME XL WAS USED IN THE PAPILLA DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE ULTRATOME XL BROKE AND THE DEVICE WAS REMOVED THROUGH THE ENDOSCOPE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND ULTRATOME XL. 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 21050397 ↗
• MalfunctionDec 27, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ULTRATOME XL USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE CUTTING WIRE OF THE ULTRATOME XL BROKE. ANOTHER OF THE SAME DEVICE WAS USED BUT THEY ENCOUNTERED THE SAME PROBLEM. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD ULTRATOME XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028626 ↗
• MalfunctionDec 27, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ULTRATOME XL USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE CUTTING WIRE OF THE ULTRATOME XL BROKE. ANOTHER OF THE SAME DEVICE WAS USED BUT THEY ENCOUNTERED THE SAME PROBLEM. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD ULTRATOME XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028624 ↗
• MalfunctionDec 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 ULTRATOME XL WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE ULTRATOME XL 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909991 ↗
• MalfunctionOct 30, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE PAPILLA VATERI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE ULTRATOME XL BROKE WHEN THE WIRE WAS TIGHTENED. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND ULTRATOME XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE OUTSIDE PACKAGE WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568105 ↗
• MalfunctionAug 20, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. 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 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 20005845 ↗
• MalfunctionJun 28, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS OBSERVED THAT THERE WAS A RESISTANCE IN THE HYDROPHILIC PART OF THE GUIDEWIRE WHEN PASSING AND REMOVING THE ULTRATOME XL DURING CHANNELING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE INSIDE THE POUCH WAS PROVIDED BY THE CUSTOMER WITH NO VISIBLE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638239 ↗
• MalfunctionJun 28, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS OBSERVED THAT THERE WAS A RESISTANCE IN THE HYDROPHILIC PART OF THE GUIDEWIRE WHEN PASSING AND REMOVING THE ULTRATOME XL DURING CHANNELING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE INSIDE THE POUCH WAS PROVIDED BY THE CUSTOMER WITH NO VISIBLE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638181 ↗