Trapezoid RX M00510860Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08714729296379), received between Apr 26, 2017 and Mar 3, 2026 — classified as 1 death, 20 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 53 reports, in the reporter's own words as published by the FDA.

• 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 BROKE DURING THE PROCESS OF CRUSHING A BILIARY STONE. 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 24500675 ↗
• InjuryJan 28, 2026Difficult to Remove; Use of Device Problem; Separation Failure; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A TRAPEZOID RX WAS USED IN THE BILIARY TRACT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TRAPEZOID RX WAS USED WITH AN ALLIANCE GUN TO ATTEMPT TO CRUSH A 1 CM BUT VERY HARD STONE. HOWEVER, THE STONE COULD NOT BE CRUSHED, AND THE CATHETER WAS STUCK WHEN PHYSICIAN TRIED TO PULL THE TRAPEZOID OUT. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN USED A SPYGLASS TO BREAK THE STONE, REMOVE THE BASKET, AND THEN EXTRACT THE STONE USING A BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203051 ↗
• MalfunctionNov 5, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2025. DURING THE PROCEDURE, THE HANDLE ATTACHED TO ALLIANCE GUN TO BREAK TIP, HOWEVER, THE HANDLE OF THE TRAPEZOID BROKE, LEAVING JUST THE WIRE. OLYMPUS DEVICE USED TO TIGHTEN AND COIL WIRE USED, EVENTUALLY TIP OF TRAPEZOID DETACHED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476860 ↗
• InjuryOct 1, 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 A TRAPEZOID RX WAS USED IN THE PANCREATIC DUCT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN CAPTURED THE STONE USING A 1.5 CM BASKET. HOWEVER, THE TECHNICIAN WAS UNABLE TO FRACTURE THE STONE MANUALLY, SO THEY ATTACHED THE ALLIANCE INFLATION HANDLE. A POPPING SOUND WAS HEARD, AND IT WAS INITIALLY THOUGHT THAT THE TIP HAD BROKEN OFF. UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT THE HANDLE HAD SEPARATED FROM THE WIRE, AND THE BASKET REMAINED IN THE PANCREATIC DUCT AROUND THE STONE. THE PHYSICIAN ATTEMPTED TO PULL THE WIRES TO RETRIEVE THE BASKET FROM THE DUCT. THEY THEN DECIDED TO DILATE THE DUCT USING AN 8 MM HURRICANE BALLOON. AFTER TWO INFLATIONS, THE PHYSICIAN WAS ABLE TO EXTRACT THE BASKET FROM THE DUCT. THE SCOPE WAS REMOVED FROM THE PATIENT WITH THE BASKET STILL INSIDE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190455 ↗
• MalfunctionSep 9, 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 IS 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 23008817 ↗
• MalfunctionApr 28, 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 A FIBER CHOLEDOCHOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE COMMON BILE DUCT STUNE COULDN'T BE CRUSHED, AND THE BASKET TIP COULDN'T BE DISENGAGED. 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 21918343 ↗
• MalfunctionNov 1, 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 TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE HANDLE WAS BROKEN. 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 20589750 ↗
• InjuryAug 29, 2024Premature Activation; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Premature Activation; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE CBD STONE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, PRIOR TO CAPTURING THE STONE, THE BASKET DETACHED. THE BASKET WAS REMOVED FROM THE PATIENT; HOWEVER, THE BASKET TIP WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX BASKET. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

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

  MAUDE report 20102499 ↗
• InjuryJun 24, 2024Break; Use of Device Problem; Failure to Disconnect; Separation Failure; Break; Use of Device Problem; Failure to Disconnect; Separation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) 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, A TRAPEZOID RX BASKET WAS USED TO RETRIEVE A MIGRATED NON-BSC PLASTIC STENT; HOWEVER, THE BASKET GOT TRAPPED AROUND THE STENT. THE PATIENT UNDERWENT OPEN SURGERY ON THE SAME DAY TO HAVE THE BASKET REMOVED. THE PATIENT'S CONDITION FOLLOWING THE SURGERY WAS STABLE AND THEY WERE ADMITTED BEYOND THE STANDARD OF CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594116 ↗
• MalfunctionApr 19, 2024Material Deformation; Material Split, Cut or Torn; 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 THE PROCEDURE, THE TIP OF THE SIDE CAR RX WAS FOUND TORN. ANOTHER TRAPEZOID RX WAS USED TO COMPLETE THE PROCEDURE. 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 FINDING OF SIDE CAR RX PUSHBACK. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143371 ↗
• MalfunctionApr 18, 2024Material Deformation; Material Split, Cut or Torn; 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 PREPARATION, THE TRAPEZOID RX WAS INSPECTED AND OBSERVED THE BASKET WAS ABLE TO OPEN AND CLOSE. HOWEVER, THE SIDE CAR RX GUIDEWIRE CHANNEL WAS FOUND SPLIT INTO TWO AND PUSHED BACK. 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 19139788 ↗
• InjuryJan 31, 2024Break; Use of Device Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Use of Device Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER BASKET WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TRAPEZOID RX BASKET WAS USED IN AN ATTEMPT TO REMOVE A STONE FROM THE PANCREATIC DUCT. THE STONE WAS A BIT LARGE, IN WHICH THE BASKET COULD NOT BREAK THE STONE. AN ALLIANCE HANDLE WAS USED IN AN ATTEMPT TO CRUSH THE STONE AND DETACH THE TIP OF THE BASKET. HOWEVER, THE BASKET GOT STUCK IN THE PANCREATIC DUCT. IT WAS ALSO NOTED THAT THE PULL WIRE WAS BROKEN. FORTUNATELY, AFTER SEVERAL MOBILIZATIONS BY OPENING AND CLOSING, THE BASKET WAS ABLE TO BE REMOVED. A PANCREATIC STENT WAS PLACED, AND THE PROCEDURE ENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS IN INPATIENT CARE BEING MONITORED AND DOING WELL AT THIS TIME. THERE IS NO DATE AS TO WHEN THE PATIENT WILL BE TAKEN BACK FOR EXAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618998 ↗
• MalfunctionJan 26, 2024Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE SIDE CAR RX WAS PUSHED BACK. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587061 ↗
• InjuryDec 14, 2023Break; 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) 2023. DURING THE PROCEDURE, THE HANDLE CANNULA OF THE TRAPEZOID RX BROKE WHILE ATTEMPTING TO CRUSH A 9MM STONE WITH AN ALLIANCE HANDLE. THE BASKET COULD NO LONGER BE REMOVED. ATTEMPTS TO REMOVE THE BASKET WAS PERFORMED BY DILATING THE DUCT AND USING AN EXTRACTION BALLOON ABOVE THE STONE. A NON-BSC RESCUE HANDLE WAS USED TO ATTEMPT TO DETACH THE TIP OF THE BASKET, BUT THE PULL WIRE BROKE ONCE WRAPPED AROUND THE RESCUE HANDLE. A PLASTIC STENT WAS IMPLANTED TO ENSURE BILIARY DRAINAGE AND THE WIRE WAS TAPED TO PATIENT'S CHEEK. THE PATIENT WAS SENT TO RECOVERY AND WAS LATER TRANSFERRED TO ST. PAUL'S HOSPITAL FOR REMOVAL OF THE BASKET.

  Patient problems: Foreign Body In Patient

  MAUDE report 18330640 ↗
• MalfunctionAug 16, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE THUMB RING BROKE. THERE WAS A STONE INSIDE THE BASKET AT THE TIME, HOWEVER IT IS UNKNOWN HOW THE STONE WAS REMOVED FROM THE BASKET. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560970 ↗
• InjuryJul 17, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BASKET WIRE GOT DETACHED AND REMAINED IN THE PATIENT'S BILE DUCT. THE CUSTOMER MENTIONED THAT THE WIRE THAT BECAME DETACHED HAD BEEN REMOVED FROM THE PATIENT, BUT THEY DID NOT SPECIFY THE DEVICE USED FOR ITS REMOVAL. ANOTHER TRAPEZOID RX BASKET 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 17332682 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE THUMB RING BROKE IN AN ATTEMPT TO CRUSH A STONE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315403 ↗
• MalfunctionJan 11, 2023Separation Failure; Difficult to Open or Close; Separation Failure; Difficult to Open or Close

  IT WAS REPORTED THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A TRAPEZOID BASKET WAS USED TO CRUSH A STONE. HOWEVER, THE BASKET WAS DIFFICULT TO OPEN AND CLOSE WHEN THE HANDLE WAS ACTUATED. THE STONE WAS EVENTUALLY FREED FROM THE BASKET AFTER SEVERAL ATTEMPTS. THE BASKET WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2023, IT WAS CONFIRMED THAT THE TIP OF THE BASKET DID NOT DETACH WHEN AN ALLIANCE HANDLE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141244 ↗
• MalfunctionJan 9, 2023Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Difficult to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE LUMEN TIP WAS FLATTENED, WHICH APPEARED TO BE THE CAUSE OF THE GUIDEWIRE'S INABILITY TO INSERT SMOOTHLY. ANOTHER TRAPEZOID BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE SIDE CAR RX WAS PUSHED BACK; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120681 ↗
• MalfunctionNov 17, 2022Break; Break

  THIS REPORT PERTAINS TO ONE OF MULTIPLE TRAPEZOID RX LITHOTRIPTER BASKETS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO TRAPEZOID RX LITHOTRIPTER BASKETS WERE USED IN A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A TRAPEZOID BASKET WAS USED IN CONJUNCTION WITH AN ALLIANCE HANDLE IN AN ATTEMPT TO CRUSH A STONE. HOWEVER, THE THUMB RING OF THE TRAPEZOID BROKE. ANOTHER TRAPEZOID RX BASKET WAS USED WITH AN ALLIANCE HANDLE; HOWEVER, THE SAME PROBLEM OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820545 ↗
• InjuryOct 6, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT DURING A COMPLETE ENDOSCOPIC SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE TRAPEZOID RX BASKET CAPTURED A STONE. HOWEVER, THE METAL SHEATH TORE AND THERE WAS DIFFICULTY REMOVING THE DEVICE. BY FORCE OF MANIPULATION, THE BASKET WAS SUCCESSFULLY EXTRACTED. THE PROCEDURE WAS CONTINUED BY A NEW CATHETERIZATION. BLEEDING ON THE SPHINCTEROTOMY ORIFICE WAS NOTED AND A SELF-EXPANDING METAL STENT WAS PLACED TO STOP THE BLEEDING. THERE WAS AN INCREASED PROCEDURAL TIME OF ABOUT 1 HR TO 1HR 30 MINS. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15556317 ↗
• MalfunctionSep 14, 2022Separation Failure; Separation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A TRAPEZOID RX BASKET WAS USED IN CONJUNCTION WITH AN ALLIANCE HANDLE IN AN ATTEMPT TO CRUSH A STONE. HOWEVER, THE BASKET FAILED TO CRUSH THE STONE AND THE TIP FAILED TO SEPARATE. THE STONE WAS REMOVED FROM THE BASKET BY OPENING THE WIRES. AN EXTRACTOR PRO WAS USED TO COMPLETE THE PROCEDURE. 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 15421882 ↗
• MalfunctionAug 19, 2022Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO TRAPEZOID RX BASKETS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN (B)(6) 2022. DURING THE PROCEDURE, THE THUMB RING BROKE IN AN ATTEMPT TO CRUSH A STONE. ANOTHER TRAPEZOID RX BASKET WAS USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE COMPLETED WITH THE THIRD TRAPEZOID RX BASKET. THERE WERE NO PATIENT COMPLICATIONS 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 15258327 ↗
• InjuryMar 8, 2022Break; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Break; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AN ALLIANCE II HANDLE WAS USED IN CONJUNCTION WITH THE TRAPEZOID BASKET IN AN ATTEMPT TO CRUSH A 9 MM STONE. HOWEVER, THE PULL WIRE BROKE AND THE BASKET WAS STUCK INSIDE THE BILE DUCT. WITH THE STONE STILL INSIDE THE BASKET, A HURRICANE BALLOON WAS USED TO REMOVE THE STONE FROM THE BASKET. 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 13690649 ↗
• InjuryDec 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO TRAPEZOID RX BASKETS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SIDE CAR-RX TUNNEL (GUIDEWIRE CHANNEL) WAS TORN DURING REMOVAL. ANOTHER TRAPEZOID BASKET WAS USED BUT THE SIDE CAR TORE WHEN PASSING DOWN THE SCOPE. FIBERS OF THE TORN SIDE CAR WERE FOUND LEFT IN THE DUCT AND DUODENUM. THE FIBERS WERE RETRIEVED USING A RAT TOOTH FORCEPS AND ANOTHER TRAPEZOID BASKET 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 12924321 ↗