Stonetome M00535150Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 08714729146667), received between Jun 13, 2018 and Sep 28, 2026 — classified as 2 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (43 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923042 ↗
• MalfunctionJun 8, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE STONETOME WAS INSERTED INTO THE ENDOSCOPE FORCEPS CHANNEL AND USED, THE CUTTING WIRE APPEARED TO BE ORIENTED IN THE OPPOSITE DIRECTION THAN USUAL. THE PROCEDURE WAS COMPLETED WITH 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 KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435616 ↗
• MalfunctionJan 14, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ATTEMPTING TO USE THE STONETOME, AN ABNORMALITY WAS OBSERVED IN THE DIRECTION OF THE CUTTING WIRE. THE PROCEDURE WAS COMPLETED WITH 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 FINDING OF DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075991 ↗
• MalfunctionJan 9, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STONETOME DEVICE WAS INSERTED INTO THE FORCEPS CHANNEL. WHEN THE CUTTING WIRE WAS PULLED AND OPERATED, THE BLADE APPEARED ORIENTED TOWARD THE 1 O CLOCK POSITION INSTEAD OF THE EXPECTED NEUTRAL ALIGNMENT. THE PROCEDURE WAS COMPLETED WITH 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 FINDING OF DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24025549 ↗
• MalfunctionOct 31, 2025Failure to Conduct; Material Deformation; Failure to Conduct; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING A STONE REMOVAL SURGERY PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, ENERGIZATION WAS NOT POSSIBLE, AND INCISION COULD NOT BE PERFORMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 FINDING OF A CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441331 ↗
• MalfunctionFeb 12, 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 STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA OF THE DUODENUM DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE HAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369347 ↗
• MalfunctionOct 16, 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 STONETOME WAS BEING PREPARED FOR USE IN A PROCEDURE TO BE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE CUTTING WIRE HAD DETACHED BEFORE INSERTING IT INTO THE ENDOSCOPE CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE FROM A DIFFERENT LOT NUMBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463900 ↗
• MalfunctionAug 17, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS INTENDED TO BE USED IN THE PAPILLA DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTICED THAT THE TIP OF THE STONETOME WAS DAMAGED AS THE TIP OF THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH 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 MOLDING TIP WAS DETACHED FROM THE CURVING MANDREL. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17567655 ↗
• MalfunctionJul 24, 2023Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS INTENDED TO BE USED IN THE BILE DUCT DURING A BILIARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PREPARATION OUTSIDE THE PATIENT, AN ATTEMPT WAS MADE TO REMOVE THE STYLET FROM THE TIP OF THE STONETOME; HOWEVER, THE TIP OF THE STYLET BENT AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH 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 MOLDING TIP WAS DETACHED FROM THE CURVING MANDREL. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383263 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE BILE DUCT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, WHEN HIGH FREQUENCY WAS APPLIED, THE CUTTING WIRE OF THE STONETOME GOT SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203769 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE BILE DUCT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON JUNE 6, 2023. DURING THE ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, WHEN HIGH FREQUENCY WAS APPLIED, THE CUTTING WIRE OF THE STONETOME GOT SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199642 ↗
• MalfunctionMay 16, 2023Failure to Fold; Detachment of Device or Device Component; Failure to Fold; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PROCEDURE, THE CUTTING WIRE OF THE STONETOME SEEMED TO BE GLUED TO THE TIP AS IT WOULD NOT BEND. THE PROCEDURE WAS COMPLETED WITH 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 MOLDING TIP WAS DETACHED FROM THE CURVING MANDREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940193 ↗
• MalfunctionApr 21, 2023Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A STONETOME WAS INTENDED TO BE USED IN THE PAPILLA DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION OUTSIDE THE PATIENT, WHEN THE STYLET WAS PULLED OUT FROM THE TIP OF THE STONETOME, IT COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH 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 MOLDING TIP WAS DETACHED FROM THE CURVING MANDREL. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787159 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, "THE CUTTING WIRE PART GOT SEPARATED." THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687157 ↗
• MalfunctionJan 25, 2023Failure to Fold; Detachment of Device or Device Component; Failure to Fold; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE BILE DUCT DURING A BILIARY LITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE OUTSIDE THE PATIENT, THE WIRE WOULD NOT BEND. IT WAS REPORTED THAT "SOMETHING LIKE A STYLET AT THE TIP OF THE CATHETER WAS FOUND TO BE BENT." ADDITIONALLY, "THE STYLET WAS BROKEN. THERE WERE NOT ANY OTHER PROBLEMS, BUT THE BEND WAS BAD BECAUSE OF THE STYLET." 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 16240699 ↗
• MalfunctionNov 21, 2022Break; Failure to Fold; Material Deformation; Material Integrity Problem; Break; Failure to Fold; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS INTENDED TO BE USED IN THE PAPILLA DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE HANDLE WAS STIFF SO THE DEVICE WOULD NOT BOW AND THERE WERE KINK MARKS ON THE PLASTIC CATHETER TIP. THE PROCEDURE WAS COMPLETED WITH 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 WIRE AT THE HANDLE SECTION WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839812 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INCISE THE DUODENAL PAPILLA. THE DEVICE WAS ABLE TO CUT AND HAD NO PROBLEM WITH THE CUTTING WIRE DURING THE FIRST ENERGIZATION. HOWEVER, DURING THE SECOND ENERGIZATION, THE CUTTING WIRE WAS DETACHED FROM THE TIP PART WHERE THE GREEN MARKER WAS LOCATED. THE CUTTING WIRE WAS CUT FROM THE BASE PART TO PREVENT DAMAGING THE INSIDE OF THE SCOPE, AND THE SCOPE WAS REMOVED FROM THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15339571 ↗
• MalfunctionJul 27, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING A PAPILLARY INCISION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CUTTING WIRE OF THE STONETOME 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 15112171 ↗
• InjuryJul 22, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE TIP OF THE FORMING MANDREL WAS DETACHED FROM THE DEVICE AND FELL INTO THE PATIENT. THE DETACHED TIP WAS RETRIEVED USING A FORCEPS. 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 SHOWS THE DETACHED TIP OF THE FORMING MANDREL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15086404 ↗
• MalfunctionFeb 2, 2022Break; Failure to Align; Material Twisted/Bent; Positioning Problem; Break; Failure to Align; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT "THE AXIS OF THE NIPPLE DID NOT FIT WELL WITH THE DEVICE, SO TORQUE WAS APPLIED TO THE DEVICE TO TURN IT IN THE AXIAL DIRECTION. THEN, WHEN THE KNIFE WAS PULLED OUT, IT TWISTED ALONG WITH THE CATHETER, WHICH RESULTED IN A DIFFERENT ORIENTATION AND ANGLE THAN NORMAL. THE KNIFE PART WAS SEPARATED WHILE TRYING TO TURN IT BACK". IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. ADDITIONALLY, IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO CUT THROUGH STONES. 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 13425298 ↗
• MalfunctionDec 3, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC BILIARY STONE CRUSHING PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, WHEN ENDOSCOPIC SPHINCTEROTOMY (EST) WAS BEING PERFORMED, "THE BLADE OF THE KNIFE TURNED TO 3 O'CLOCK INSTEAD OF 11 O'CLOCK, AND EST COULD NOT BE PERFORMED." IT WAS REPORTED THAT EVEN IF THE CUTTING WIRE WAS IN A RELAXED POSITION, THE CUTTING WIRE SEEMED TOWARDS ON THE RIGHT SIDE, WHICH WAS NOT NORMAL. THERE WAS NO ANY VISIBLE DAMAGE NOTED TO THE DEVICE AFTER THE PROBLEM OCCURRED. 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 12925760 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, ENDOSCOPIC SPHINCTEROTOMY (EST) WAS PERFORMED USING THE STONETOME. DURING ENERGIZATION, THE CUTTING WIRE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506539 ↗
• MalfunctionSep 10, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE MAIN PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE STONETOME EXITED THE SCOPE, IT WAS NOTICED THAT THE ORIENTATION OF THE CUTTING WIRE WAS INCORRECT AND SO THEY THEN DECIDED TO DISCONTINUE USING THE DEVICE. THE PROCEDURE WAS COMPLETE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455183 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE OF THE STONETOME 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335726 ↗
• MalfunctionAug 11, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHEN THE DEVICE EXITED THE SCOPE, IT WAS NOTICED THAT THE CUTTING WIRE OF THE STONETOME 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309306 ↗