Trapezoid RX M00510880Recalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 08714729296393), received between Dec 7, 2016 and Sep 22, 2026 — classified as 1 death, 64 injuries, 222 malfunctions.

The most frequently reported specific device problem is “Break” (163 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 287 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break; Difficult to Remove; 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) 2026.During the procedure, a Trapezoid RX was used with an Alliance II Handle to attempt to crush a 10mm biliary stone. However, the handle cannula broke. The basket was manually removed from the biliary duct but with difficulty. Another Trapezoid RX was used to complete the procedure.No patient complications were reported; however, the procedure took longer than anticipated due to the equipment fault. The patient's condition following procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850698 ↗
• MalfunctionSep 22, 2026Break

  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)2026. During the procedure, the thumb ring broke during the process of crushing the biliary stone. The procedure was completed with another of the same device.There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850328 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50297050 ↗
• MalfunctionJun 24, 2026Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE OUTER SHEATH WAS TORN. 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 25604251 ↗
• MalfunctionJun 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE OUTER SHEATH WAS DESQUAMATED. IT WAS LATER CONFIRMED THAT THE SHEATH WAS TORN OR PEELED OFF. 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 25566212 ↗
• InjuryJun 1, 2026Break; Difficult to Remove; Use of Device Problem; Separation Failure; Difficult to Open or Close

  BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A TRAPEZOID RX THROUGH THE ARTICLE "FRAYED TO FURY: ARGON PLASMA COAGULATION FOR TRAPEZOID BASKET RETRIEVAL IN THE PANCREATIC DUCT." BY ZAKARIA, NOVAL, ET AL. ACCORDING TO THE ARTICLE, THE TRAPEZOID RX WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR STONE EXTRACTION PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, SPHINCTEROPLASTY WAS PERFORMED UP TO 8MM THROUGH CONTROLLED RADIAL EXPANSION BALLOON, FOLLOWED BY INSERTION OF A TRAPEZOID RX FOR STONE EXTRACTION. A BALLOON CATHETER WAS ADVANCED OVER THE GUIDEWIRE; HOWEVER, EXTRACTION OF THE STONES COULD NOT BE ACHIEVED. A TRAPEZOID RX WAS THEN INSERTED, AND THE STONES WERE SUCCESSFULLY CAPTURED. MECHANICAL LITHOTRIPSY WAS ATTEMPTED, BUT THE LITHOTRIPTER HANDLE CATHETER BROKE, RESULTING IN BASKET IMPACTION WITH THE STONE. ATTEMPTS AT SIDE-BY-SIDE SPHINCTEROPLASTY WERE UNSUCCESSFUL IN RETRIEVING THE IMPACTED BASKET-STONE COMPLEX. THE DUODENOSCOPE WAS WITHDRAWN AFTER THE HANDLE OF THE BASKET WAS CUT. A SPHINCTEROPLASTY OF 10 MM WAS THEN PERFORMED, AFTER WHICH THE BASKET WIRES MANAGED TO EVERT IN THE DUODENUM. AS A RESCUE MEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349226 ↗
• MalfunctionMay 21, 2026Break; 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 A MECHANICAL LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2028. DURING PROCEDURE, WHEN USING THE ALLIANCE HANDLE, THE HANDLE CANNULA SNAPPED INSTEAD OF THE BASKET TIP BREAKING OFF. THE STONE FORTUNATELY FELL OUT OF THE BASKET. A DIFFERENT DEVICE AND A PLASTIC STENT WERE 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 25242195 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE GALLBLADDER FOR GALLSTONE REMOVAL DURING A GALLBLADDER LITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STEEL WIRE WAS FRACTURED. BASKED ON THE PHOTO PROVIDED BY THE COMPLAINANT, THE HANDLE CANNULA WAS BROKEN. 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 25116560 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED TO TREAT CALCULUS IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STEEL WIRE WAS FRACTURED AND THE SUBSEQUENT OPERATION COULD NOT BE PERFORMED. THE CUSTOMER WAS REFERRING TO THE BASKET WIRE. 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 25116534 ↗
• MalfunctionApr 29, 2026Break; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT TO CAPTURE A STONE DURING STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BASKET WOULD NOT OPEN IN THE COMMON BILE DUCT. IT WAS ALSO REPORTED THAT THERE WAS A STONE OUTSIDE THE BASKET WHEN IT FAILED TO OPEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF HANDLE CANNULA DETACHED OR SEPARATED. PLEASE SEE DEVICE ANALYSIS RESULTS FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033783 ↗
• MalfunctionApr 24, 2026Premature Activation; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED TO CAPTURE A STONE IN THE BILE DUCT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STONE WAS GRASPED AND CAPTURED, BUT THE DISTAL TIP UNEXPECTEDLY CAME OFF, AND GRASPING THE STONE WAS IMPOSSIBLE. IT WAS ALSO REPORTED THAT THE TIP THAT GOT DETACHED INSIDE THE BODY WILL LIKELY BE EXPELLED NATURALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978326 ↗
• MalfunctionApr 24, 2026Break; Use of Device Problem

  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) 2026. DURING THE PROCEDURE, AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX TO ATTEMPT TO CRUSH A BILIARY STONE. HOWEVER, THE THUMB RING OF THE TRAPEZOID RX BROKE AND THE STONE WAS UNABLE TO BE CRUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24977839 ↗
• MalfunctionApr 21, 2026Break; Use of Device Problem

  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) 2026. DURING THE PROCEDURE, AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX TO ATTEMPT TO CRUSH A BILIARY STONE. HOWEVER, THE THUMB RING OF THE TRAPEZOID RX BROKE AND STONE WAS UNABLE TO BE CRUSH. 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 24943785 ↗
• InjuryApr 17, 2026Break; Difficult to Remove; Use of Device Problem; Separation Failure; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER BASKET WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR CBD STONE REMOVAL PERFORMED ON (B)(6) 23, 2026. DURING THE PROCEDURE, AFTER THE STONE WAS CAPTURED, THE BASKET COULD NOT BE PULLED THROUGH THE PAPILLA. THE TRAPEZOID RX BASKET WAS THEN CONNECTED TO AN ALLIANCE HANDLE TO PERFORM LITHOTRIPSY. DURING LITHOTRIPSY, THE BASKET FRACTURED AT THE HANDLE END, AND THE SAFETY RELEASE MECHANISM DID NOT ACTIVATE TO ALLOW RELEASE OF THE STONE FROM THE BASKET. A SECOND TRAPEZOID RX BASKET WAS USED; HOWEVER, THIS BASKET HANDLE ALSO FRACTURED DURING LITHOTRIPSY. AS A RESULT, THE BASKET WITH THE IMPACTED STONE WAS LEFT IN THE PATIENT, AND THE PROCEDURE WAS DISCONTINUED AND RESCHEDULED FOR THE FOLLOWING DAY. ON THE NEXT DAY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING SPYGLASS AND AN EHL PROBE TO PERFORM LITHOTRIPSY AND REMOVE THE STONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE FOLLOWING THE SUCCESSFUL COMPLETION OF THE RESCHEDULED PROCEDURE. NOTE: THIS REPORT PERTAINS TO THE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912540 ↗
• MalfunctionApr 2, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS TO BE USED TO CAPTURE A LARGE BILE DUCT STONE IN THE COMMON BILE DUCT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, IT WAS REPORTED THAT THE BASKET 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 AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762448 ↗
• MalfunctionMar 19, 2026Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING A CBD STONE PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE TRAPEZOID RX WAS UNPACKED AND FOUND TO HAVE A KINK AT THE DISTAL TIP. THE DEVICE WAS THEN TESTED AND THE HANDLE CANNULA BROKE WHEN THE HANDLE WAS ACTUATED. A PICTURE WAS PROVIDED BY THE CUSTOMER SHOWING THE HANDLE CANNULA WAS BROKEN. 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 24645166 ↗
• MalfunctionMar 3, 2026Break

  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) 2026. DURING THE PROCEDURE, THE HANDLE OF THE TRAPEZOID RX WAS BROKEN DURING THE PROCESS OF BREAKING A BILIARY STONE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500604 ↗
• MalfunctionFeb 26, 2026Break; 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) 2026. DURING THE PROCEDURE, THE HANDLE CANNULA BROKE WHEN TRYING TO CRUSH A STONE APPROXIMATELY 1CM. THE BASKET WAS PULLED OUT OF THE SCOPE. PROCEDURE WAS PROLONGED BY LESS THAN 5 MINUTES AND WAS COMPLETED WITH AN EXTRACTOR BALLOON 9-12MM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461807 ↗
• MalfunctionFeb 5, 2026Break; 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 COMMON BILE DUCT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AN ALLIIANCE HANDLE WAS USED WITH THE TRAPEZOID RX TO ATTEMPT TO FRAGMENT A STONE. HOWEVER, THE STONE WAS HARD AND COULD NOT BE CRUSHED, THE EXACT SIZE OF THE STONE WAS NOT PROVIDED; HOWEVER, BASED ON THE INFORMATION RECEIVED, IT WAS LESS THAN 2.5 CM. THE TIP OF THE BASKET FAILED TO SEPARATE, LEAVING THE STONE STUCK IN THE BASKET. THE ALLIANCE HANDLE WAS PUSHED TO ITS MECHANICAL LIMITS, AND IT APPEARED THAT THE HANDLE CANNULA WAS BROKEN. FORTUNATELY, THE STONE FELL OUT BY ITSELF AS THEY WERE MOVING THE CATHETER. THE STONE WAS LEFT INSIDE THE BILE DUCT. A PLASTIC STENT WAS USED TO ENSURE BILE FLOW AND SOMETIMES TO CRUSH THE STONE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273052 ↗
• MalfunctionJan 7, 2026Break

  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 ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE "THE BASKET WIRE COULD BE BROKEN". THE PROCEDURE WAS COMPLETED USING ANOTHER TRAPEZOID RX. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 08, 2026 THE TIP OF THE BASKET WAS INTENTIONALLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990984 ↗
• 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 23971881 ↗
• MalfunctionDec 8, 2025Break; Break

  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 THE PROCEDURE, THE HANDLE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743538 ↗
• MalfunctionOct 21, 2025Break; Break

  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 THE PROCEDURE, THE DEVICE SPLIT AT ITS DISTAL END. NO INFORMATION WAS PROVIDED REGARDING THE PROCEDURE OUTCOME. NO INFORMATION WAS PROVIDED REGARDING THE PATIENT'S OUTCOME. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351156 ↗
• MalfunctionAug 7, 2025Difficult to Open or Close; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Material Twisted/Bent; 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 PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE HANDLE COULD NOT BE OPENED, AND IT WAS FOUND THE HANDLE CANNULA WAS "LIFTED UP". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 22740264 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING PREPARATION, IT WAS NOTICED THAT THE WIRE AT THE TIP OF THE BASKET WAS FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER TRAPEZOID RX. THERE WERE NO PATIENT COMPLICATIONS 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 22167855 ↗