Trapezoid RX M00510870Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 08714729296386), received between Nov 22, 2016 and May 29, 2026 — classified as 41 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Break” (81 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 149 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP SHEATH OF THE BASKET WAS DAMAGED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. HOWEVER, THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336416 ↗
• MalfunctionMay 14, 2026Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, IT WAS OBSERVED THAT THERE WAS A CRACK NEAR THE RX PORT, CAUSING THE GUIDEWIRE TO COME OUT THROUGH THE CRACK. 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 25176417 ↗
• MalfunctionJan 23, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE HANDLE OF THE TRAPEZOID RX WAS BROKEN DURING THE ATTACHMENT TO THE ALLIANCE GUN. ANOTHER TRAPEZOID RX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158817 ↗
• InjuryJan 8, 2026Break; Use of Device Problem; Separation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, A STONE WAS CAPTURED WITHIN THE BASKET, AND AN ALLIANCE HANDLE WAS USED IN AN ATTEMPT TO BREAK THE STONE. THE STONE DID NOT FRACTURE, AND THE BASKET TIP DID NOT DISENGAGE. IT WAS SUBSEQUENTLY OBSERVED THAT THE INTERNAL WIRE WITHIN THE HANDLE HAD BROKEN. AN OLYMPUS SOEHENDRA LITHOTRIPTER WAS THEN USED TO DISENGAGE THE TIP OF THE TRAPEZOID RX BASKET AND RELEASE THE STONE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012862 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE HANDLE BROKE WHILE ATTACHING THE DEVICE TO THE ALLIANCE HANDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER TRAPEZOID RX. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971882 ↗
• InjuryDec 23, 2025Break; Use of Device Problem; Separation Failure; Break; Use of Device Problem; Separation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ALLIANCE II HANDLE WAS USED IN CONJUNCTION WITH THE TRAPEZOID RX TO ATTEMPT STONE EXTRACTION OF A 1.5-2.0 CM STONE. DURING USE, THE HANDLE BROKE, AND THE BASKET TIP FAILED TO SEPARATE FROM THE BASKET. THE DISTAL BILE DUCT WAS SUBSEQUENTLY DILATED USING A 4 MM HURRICANE BALLOON IN AN ATTEMPT TO REMOVE THE BASKET AND STONE; HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP ERCP WITH SPYGLASS/LASER LITHOTRIPSY ON (B)(6) 2025, TO FRAGMENT THE STONE AND FACILITATE BASKET REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874664 ↗
• MalfunctionOct 1, 2025Use of Device Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX. HOWEVER, THE BASKET WAS UNABLE TO CRUSH THE STONE, AND THE TIP OF THE BASKET FAILED TO DETACHED. THE CATHETER WAS CUT, AND A SOHENDRA LITHOTRIPTER WAS USED TO DETACH THE TIP AND COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190937 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX TO CRUSH THE STONE. HOWEVER, THE HANDLE WAS BROKEN WHEN THE STONE WAS INSIDE THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085669 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS UNPACKED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING UNPACKING, THE HANDLE ASSEMBLY WAS FOUND DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION FOLLOWING PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978807 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE HANDLE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER TRAPEZOID RX. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931766 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE BILLIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE THUMB RING WAS BROKEN. ANOTHER TRAPEZOID RX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616764 ↗
• MalfunctionJan 2, 2025Premature Activation; Use of Device Problem; Premature Activation; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BASKET TIP BROKE OFF WHILE ATTEMPTING TO CRUSH THE STONE. THE TIP WAS VISUALIZED IN THE DUODENUM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057303 ↗
• MalfunctionSep 18, 2024

  DURING THE CASE, A WIRE GUIDED RETRIEVAL BASKET WAS DEPLOYED, THE GALLSTONE WAS CAPTURED IN THE BASKET AND WAS ATTEMPTED TO BE CRUSHED WITH THE PRODUCT. WHEN DOING SO, THERE IS A FAILSAFE, WHERE THE TIP OF THE BASKET POPS OFF IF THE STONE IS UNABLE TO BE CRUSHED. WHEN THIS TIP COMES OFF, THE BASKET CAN THEN SLIP OFF THE STONE AND BE REMOVED. IN THIS CASE THE TIP DID NOT DETACH, WHICH CAUSED THE BASKET TO BE STUCK ON THE STONE. THE BASKET WITH THE STONE WAS ATTEMPTED TO BE REMOVED FROM THE PATIENT; HOWEVER, IT WAS TOO LARGE AND WHENEVER THE WIRE WAS PULLED THE PATIENT BEGAN TO BECOME BRADYCARDIC, DUE TO THIS THE BASKET AND STONE WAS LEFT IN THE PATIENT WITH THE GUIDEWIRE CUT AT THE DISTAL END. [REDACTED] RECOMMENDATION WAS TO TRANSFER THE PATIENT TO [REDACTED] WHERE THEY HAVE EUS, SPYGLASS AND LITHOTRIPSY. PATIENT WAS EMERGENTLY TRANSFERRED TO [REDACTED] HOSPITAL. WE DO HAVE SPYGLASS HERE BUT [REDACTED] NOR HIS PARTNERS ARE TRAINED IN USE, AND [REDACTED] FELT EUS MAY BE NEEDED, A SERVICE WE DO NOT HAVE, NOR (B)(6).

  Patient problems: Bradycardia; Foreign Body In Patient

  MAUDE report 20245806 ↗
• MalfunctionSep 6, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BASKET WAS NOT OPENING FULLY WITH A STONE INSIDE THE BASKET. THE STONE WAS NOT TOO LARGE, SO THE DEVICE WAS REMOVED AS IS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS 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 20162766 ↗
• MalfunctionSep 5, 2024Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE BASKET FELL OFF DURING STONE REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX 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 20145667 ↗
• MalfunctionAug 2, 2024Use of Device Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE BILIARY STONE WAS CAPTURED WITH THE TRAPEZOID RX BUT WOULD NOT CRUSH. IN ADDITION, THE TIP OF THE TRAPEZOID RX WOULD NOT DISENGAGE. THE BASKET AND STONE WERE ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 16, 2024. AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX TO ATTEMPT TO CRUSH THE STONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892450 ↗
• MalfunctionJul 29, 2024Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED DURING A ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE BASKET PREMATURELY DETACHED WHEN ATTEMPTING TO CRUSH A 2CM STONE. 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 19853284 ↗
• InjuryJul 15, 2024Difficult to Remove; Use of Device Problem; Separation Failure; Material Deformation; Difficult to Remove; Use of Device Problem; Separation Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRAPEZOID RX WAS USED FOR CHOLEDOCHOLITHIASIS IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A TRAPEZOID RX BASKET WAS USED TO REMOVE A 14 MM STONE. THE BASKET WIRES WERE SUCCESSFULLY PLACED AROUND THE STONE; HOWEVER, IT COULD NOT CRUSH THE STONE. THEY TRIED TO PULL THE BASKET OUT OF THE BILE DUCT, BUT IT GOT STUCK IN THE BILE DUCT. AN ALLIANCE HANDLE WAS USED TO DETACH THE TIP OF THE BASKET, BUT IT WAS NOT SUCCESSFUL. THE PATIENT UNDERWENT EXPLORATORY SURGERY WITH BILE DUCT EXPLORATION ON THE SAME DAY AND THE BASKET AND STONE WERE REMOVED SUCCESSFULLY. THE PATIENT WAS ADMITTED BEYOND STANDARD OF CARE AND WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740459 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, A METAL WIRE WAS HANGING OUT AT THE HANDLE. ANOTHER TRAPEZOID RX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370605 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HANDLE WAS BROKEN. ANOTHER TRAPEZOID RX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287341 ↗
• InjuryMay 6, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN TRYING TO CRUSH THE STONE WITH AN ALLIANCE II, THE HANDLE OF THE TRAPEZOID RX BROKE. THE WIRE OF THE TRAPEZOID RX WAS CUT, A SPYGLASS DEVICE WAS INSERTED, AND A LASER WAS USED TO BREAK THE STONE STUCK IN THE BASKET. THE TRAPEZOID RX WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248544 ↗
• MalfunctionMay 2, 2024Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE BILIARY DUCT DURING A STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE BASKET DETACHED BEFORE LITHOTRIPSY COULD BE PERFORMED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228923 ↗
• MalfunctionApr 1, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CONTRAST MEDIUM FLOWED BACK AND LEAKED FROM THE BASKET HANDLE WIRE. ANOTHER TRAPEZOID RX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SIDE CAR RX PUSHBACK. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015382 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX BASKET IN AN ATTEMPT TO CRUSH A 2 CM STONE. HOWEVER, THE HANDLE BROKE. ANOTHER TRAPEZOID RX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003157 ↗
• MalfunctionMar 28, 2024Break; Material Deformation; Material Split, Cut or Torn; Break; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE SHEATH OF THE TRAPEZOID RX WAS BROKEN. ANOTHER TRAPEZOID RX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SIDE CAR RX PUSHBACK. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999414 ↗