Flexima™ Biliary M00539270Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729162582), received between Mar 21, 2019 and Jul 16, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Break; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841760 ↗
• MalfunctionMar 3, 2026Positioning Failure; Nonstandard Device; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS INTENDED TO BE IMPLANTED TO TREAT BILE DUCT STONES IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED NORMALLY, AND THE INNER CORE ROLLED UP EASILY WHEN MANIPULATED WITH THE GUIDEWIRE. ANOTHER FLEXIMA BILIARY STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER DETACHED/SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500161 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE INTRODUCER BROKE WHILE RELEASING AND IT REMAINED IN THE OPERATING CHANNEL OF THE ENDOSCOPE BUT THEN IT WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095351 ↗
• MalfunctionJan 14, 2026Break; Positioning Failure; Stretched; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED IN THE COMMON BILE DUCT FOR STONES DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED AND IT CAN BE OBSERVED THAT THE GUIDE CATHETER WAS DETACHED, THERE ARE SOME KINKS AND AN ACCORDION LIKE PART OF THE GUIDE CATHETER WHICH SEEMED TO BE STRETCHED. IN ADDITION, THE PUSH CATHETER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066566 ↗
• MalfunctionNov 3, 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 FLEXIMA BILIARY STENT WAS TO BE IMPLANTED TO TREAT DRAINAGE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE STENT FELL OFF WHILE BEING UNPACKED. 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 23453158 ↗
• MalfunctionAug 26, 2025Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENTS WAS TO BE IMPLANTED TO TREAT A BILIARY STENOSIS IN THE GALLBLADDER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED EASILY. ANOTHER FLEXIMA BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892992 ↗
• MalfunctionApr 11, 2025Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENTS WAS IMPLANTED DURING PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE INNER CORE WAS FRACTURED, AND THE STENT COULD NOT BE DEPLOYED. ANOTHER FLEXIMA BILIARY STENTS WAS USED TO COMPLETE THE PROCEDURE. 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. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21829752 ↗
• MalfunctionMar 10, 2025Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT GALLSTONES DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FLEXIMA STENT COULD NOT BE DEPLOYED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561532 ↗
• MalfunctionFeb 4, 2025Break; Difficult or Delayed Positioning; Entrapment of Device; Stretched; Defective Device; Deformation Due to Compressive Stress; Material Deformation; Break; Difficult or Delayed Positioning; Entrapment of Device; Stretched; Defective Device; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS USED IN THE BILE DUCT TO TREAT GALLSTONE PANCREATITIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS POSITIONED AT THE TARGET SITE AND THE GUIDE CATHETER WAS MANIPULATED TO THE POINT OF NO RETURN; HOWEVER, IT WAS NOTED THAT THE GUIDE CATHETER WAS BENT, AND THE STENT COULD NOT BE DEPLOYED. SUBSEQUENTLY, THE STENT WAS REMOVED USING FOREIGN BODY FORCEPS WHICH RESULTED IN SCRAPING AND BLEEDING IN THE PATIENT'S GASTROINTESTINAL TRACT. THE BLEEDING WAS RESOLVED AND DID NOT REQUIRE ANY ADDITIONAL INTERVENTION. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE PUSH CATHETER WAS WRINKLED, THE STENT WAS KINKED, AND THE GUIDEWIRE BECAME STUCK IN THE GUIDE CATHETER. THE GUIDEWIRE WAS EVENTUALLY REMOVED BY SLOWLY REMOVING IT FROM THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY PRELOADED STENT OF A DIFFERENT SIZE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. UPDATE BASED ON REVIEW ON 24FEB20

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 21307527 ↗
• MalfunctionJan 9, 2025Break; Positioning Failure; Use of Device Problem; Defective Device; Detachment of Device or Device Component; Material Deformation; Break; Positioning Failure; Use of Device Problem; Defective Device; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS USED TO TREAT A BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. 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: IT WAS REPORTED THAT THE GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "COMPLETELY RETRACT THE GUIDEWIRE INTO THE ENDOSCOPE. IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED." ADDITIONALLY, IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE IFU STATES, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118440 ↗
• MalfunctionJun 11, 2024Positioning Failure; Use of Device Problem; Material Split, Cut or Torn; Positioning Failure; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT FOR THE TREATMENT OF CHOLANGIOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER FLEXIMA BILIARY STENT. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511387 ↗
• MalfunctionApr 2, 2024Break; Positioning Failure; Entrapment of Device; Use of Device Problem; Break; Positioning Failure; Entrapment of Device; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT AN ICTERIC SCLERA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2024. DURING THE PROCEDURE, THE DELIVERY SYSTEM WAS STUCK WITH THE GUIDEWIRE, AND THE GUIDE CATHETER BROKE. THE BROKEN GUIDE CATHETER AND DELIVERY SYSTEM WERE REMOVED IN ONE PIECE BY PULLING OUT THE GUIDEWIRE. 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 GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "COMPLETELY RETRACT THE GUIDEWIRE INTO THE ENDOSCOPE. IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CAN NOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19029223 ↗
• MalfunctionFeb 15, 2024Positioning Failure; Stretched; Use of Device Problem; Deformation Due to Compressive Stress; Material Deformation; Material Split, Cut or Torn; Positioning Failure; Stretched; Use of Device Problem; Deformation Due to Compressive Stress; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS USED TO TREAT BILIARY STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY PRELOADED STENT. 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. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "COMPLETELY RETRACT THE GUIDEWIRE INTO THE ENDOSCOPE. IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CAN NOT BE FULLY DEPLOYED." ADDITIONALLY, IT WAS ALSO REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716220 ↗
• MalfunctionJan 10, 2024Break; Positioning Failure; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED TO TREAT BILE DUCT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING UNPACKING, IT WAS NOTED THAT THE COATING OF THE GUIDE CATHETER PEELED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER FLEXIMA BILIARY STENT. 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 18487981 ↗
• MalfunctionAug 22, 2023Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA BILIARY STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE STENT COULD NOT BE DEPLOYED. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND 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 RESULTS; GUIDE CATHETER DETACHED/SEPARATED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599840 ↗
• MalfunctionMay 17, 2023Positioning Failure; Stretched; Material Deformation; Positioning Failure; Stretched; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE AMPULLA OF VATER, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PUSHER AND THE GUIDEWIRE GOT STUCK INSIDE THE DELIVERY SYSTEM AND THE STENT FAILED TO DEPLOY. A SECOND FLEXIMA BILIARY STENT WAS USED, AND THE SAME INCIDENT OCCURRED. A THIRD FLEXIMA BILIARY STENT (10F) WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950256 ↗
• MalfunctionFeb 23, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILIARY TRACT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT DID NOT FULLY DEPLOY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. 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. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432795 ↗
• MalfunctionFeb 21, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 20213. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. 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. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414513 ↗
• MalfunctionJan 18, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT FAILED TO RELEASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194170 ↗
• MalfunctionDec 14, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILIARY DRAINAGE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE GUIDE CATHETER BROKE AND THE STENT FAILED TO DEPLOY. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING IT TO BE REMOVED IN ONE PIECE AND ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED 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 15982131 ↗
• MalfunctionDec 14, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILIARY DRAINAGE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE GUIDE CATHETER BROKE AND THE STENT FAILED TO DEPLOY. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED 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 15975999 ↗
• MalfunctionSep 7, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, PERFORMED ON (B)(6) 2022. DURING PREPARATION, WHEN THEY UNPACKED THE DEVICE, IT WAS FOUND THAT THE OUTER SKIN OF DEVICE WAS DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. 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 15367620 ↗
• MalfunctionMar 23, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE GALLBLADDER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THEY ATTEMPTED TO DEPLOY THE STENT, THE INNER GUIDE CATHETER WAS FRACTURED. IT WAS REPORTED THAT THE BROKEN INNER GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13857376 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS NOTED THAT WHEN THEY TRIED TO DEPLOY THE FLEXIMA BILIARY STENT, IT BECAME BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. 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 AS NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419162 ↗
• MalfunctionJan 5, 2022Break; Positioning Failure; Material Deformation; Material Split, Cut or Torn; Break; Positioning Failure; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER WAS KINKED. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED 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 GUIDE CATHETER BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173139 ↗