Flexima™ Biliary M00539210Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729162520), received between Jan 16, 2018 and May 21, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break; Positioning Failure; Entrapment of Device; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE IMPLANTED TO TREAT STONES IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A 7 FR BY 7 CM STENT WAS ADVANCED OVER A 0.035" JAGWIRE GUIDEWIRE AND PASSED SMOOTHLY THROUGH THE WORKING CHANNEL. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE STENT FAILED TO RELEASE. THE ENTIRE STENT AND INTRODUCER ASSEMBLY WAS WITHDRAWN, AT WHICH POINT THE INTRODUCER WAS FOUND TO BE BUNCHED. THE GUIDEWIRE COULD NOT BE REMOVED BECAUSE IT REMAINED JAMMED INSIDE THE INTRODUCER, AS THE RELEASE THREAD HAD NOT DISENGAGED. ANOTHER FLEXIMA BILIARY PRELOADED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FIELD FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250425 ↗
• MalfunctionJul 15, 2025Break; Positioning Failure; Break; Positioning Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT RELEASE PROPERLY. A SECOND FLEXIMA BILIARY STENT OF THE SAME SIZE WAS USED, BUT THE SAME ISSUE RECURRED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510593 ↗
• MalfunctionJul 15, 2025Break; Positioning Failure; Break; Positioning Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT RELEASE PROPERLY. A SECOND FLEXIMA BILIARY STENT OF THE SAME SIZE WAS USED, BUT THE SAME ISSUE RECURRED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508425 ↗
• MalfunctionMay 23, 2025Break; Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Material Deformation; 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 COMMON BILE DUCT TO TREAT CHOLELITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE GRAY GUIDE CATHETER OF THE 7FR/7CM FLEXIMA STENT BROKE OFF AND THE STENT DID NOT DETACH FROM THE SET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A REVIEW OF THE PHOTO OF THE DEVICE PROVIDED SHOWED THAT THE PULL WIRE WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081846 ↗
• MalfunctionAug 12, 2024Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-03894 AND 3005099803-2024-03895 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS USED IN THE BILE DUCT FOR STRICTURE MANAGEMENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY AS THE SUTURE WAS UNABLE TO BE RELEASED. A SECOND FLEXIMA BILIARY PRELOADED STENT OF A DIFFERENT SIZE WAS USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS CANCELLED DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19969006 ↗
• MalfunctionJul 10, 2024Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS USED IN THE COMMON BILE DUCT TO TREAT A CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE WHEN THE STENT WAS ATTEMPTED TO BE RELEASED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 17, 2024: THE BROKEN INNER GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, AND THE DELIVERY SYSTEM WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715643 ↗
• MalfunctionNov 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, IT WAS NOTICED THAT THE STENT BARB AT THE DISTAL END WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 18147472 ↗
• MalfunctionOct 20, 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE STENT FAILED TO DEPLOY. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND USED TO SUCCESSFULLY 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 DETAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980743 ↗
• MalfunctionJul 31, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AFTER THE GUIDE CATHETER WAS REMOVED, THE SUTURE DID NOT RELEASE. 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 OR SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430409 ↗
• MalfunctionJun 14, 2023Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES IN THE BILIARY DUCT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE SHEATH AND GUIDEWIRE WERE REMOVED TO DEPLOY THE STENT, IT DID NOT DEPLOY PROPERLY. THE DUODENOSCOPE WAS REMOVED AND 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/SEPARATED, 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 17130741 ↗
• MalfunctionMar 14, 2023Break; Positioning Failure; Difficult to Advance; Break; Positioning Failure; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE PLACED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, IT WAS FOUND TO BE DIFFICULT TO ACCESS THE DESIRED STENT LOCATION DUE TO A SIGNIFICANT STRICTURE. ONCE THE PHYSICIAN ACCESSED THE DESIRED LOCATION, THE STENT WOULD NOT DEPLOY. THE INTERNAL SHAFT WAS STUCK WITH THE OUTSIDE SHAFT AND THERE WAS FRICTION DURING ATTEMPTED DEPLOYMENT. WHEN THE PHYSICIAN APPLIED ADDITIONAL FORCE TO DEPLOY THE STENT, THE DELIVERY SYSTEM AND STENT CAME OUT OF THE DUODENOSCOPE. THE PROCEDURE WAS PROLONGED AND THE PHYSICIAN USED AN ALTERNATIVE METHOD TO ENSURE DRAINAGE AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT OUTCOME IS EXPECTED TO FULLY RECOVER. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538501 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE INSERTION, WHEN THE PHYSICIAN UNPACKED THE STENT, IT WAS NOTICED THAT THE LEADING BARB WOULD NOT OPEN, THEREFORE IT IS NOT POSSIBLE FOR A STENT IMPLANTATION. 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/SEPARATED, 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 15434129 ↗
• MalfunctionJul 29, 2021Break; Break

  IT WAS REPORTED THAT A FLEXIMA BILIARY STENT WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. DURING PROCEDURE, IT WAS NOTED THAT THE STENT WAS INTRODUCED THROUGH THE GUIDEWIRE AND WAS POSITIONED IN THE SITE, HOWEVER THE STENT WAS UNABLE TO DEPLOY. THE PROCEDURE WAS 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 BROKEN THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. SEE INVESTIGATION SUMMARY FOR MORE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245451 ↗
• MalfunctionApr 20, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, INSIDE THE PATIENT, WHEN THE STENT WAS PLACED, THEY COULD NOT DEPLOY IT SUCCESSFULLY. 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/SEPARATED; THEREFORE, THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697449 ↗
• MalfunctionApr 19, 2021Positioning Failure; Retraction Problem; Material Deformation; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Positioning Failure; Retraction Problem; Material Deformation; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT IS TWO OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2021-01662, MFR. # 3005099803-2021-01664 AND MFR. REPORT # 3005099803-2021-01667). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILIARY DUCT PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THREE STENTS WERE DEPLOYED UNSUCCESSFULLY. IT WAS REPORTED THAT THEY HAD DIFFICULTY RELEASING THE SUTURE, AND THE SUTURE WAS TANGLED. A PHOTO OF THE DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER KINKED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT AND RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686952 ↗
• MalfunctionApr 19, 2021Positioning Failure; Retraction Problem; Material Deformation; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Positioning Failure; Retraction Problem; Material Deformation; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2021-01662, MFR. # 3005099803-2021-01664 AND MFR. REPORT # 3005099803-2021-01667). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILIARY DUCT PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THREE STENTS WERE DEPLOYED UNSUCCESSFULLY. IT WAS REPORTED THAT THEY HAD DIFFICULTY RELEASING THE SUTURE, AND THE SUTURE WAS TANGLED. A PHOTO OF THE DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER KINKED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT AND RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686554 ↗
• MalfunctionDec 14, 2020Break; Positioning Failure; Defective Device; Break; Positioning Failure; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR A SUSPECTED BILIARY STONES IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE PUSH CATHETER BROKE. THEY HAD TO PULL THE WHOLE DEVICE AND THE WIRE OUT AND HAD TO RECANNULATE AND TRIED AGAIN WITH SECOND STENT, HOWEVER THE PUSH CATHETER STILL BROKE. A THIRD STENT WAS REOPENED AND TRIED TO PUSH VERY SLOWLY, ALSO THE PHYSICIAN CHANGED THE POSITION OF THE SCOPE AND THE STENT WAS SUCCESSFULLY DEPLOYED. 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 GOOD. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS BROKEN THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11004516 ↗
• MalfunctionJan 15, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2019. THE PATIENT WAS DIAGNOSED WITH STONES IN THE BILE DUCT AND ERCP WAS PERFORMED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE CONTRAST WAS INJECTED, IT WAS FOUND THAT THERE WAS A STRICTURE IN COMMON BILE DUCT INSTEAD OF STONES. SPHINCTEROTOMY WITH PRELOADED TRUETOME JAG 44 (LOT 24064491) WAS PERFORMED AND STENT PLACEMENT WAS MADE, HOWEVER, THE STENT WAS NOT DEPLOYED AS IT IS SUPPOSED TO AND THE STENT WAS REMOVED FROM THE PATIENT. 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 Consequences Or Impact To Patient

  MAUDE report 9591035 ↗
• MalfunctionDec 24, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE FLEXIMA BILIARY STENT, THE GUIDE CATHETER BECAME TWISTED AND THE STENT WAS UNABLE TO BE RELEASED FROM THE GUIDE "CAHETER". THE PROCEDURE WAS SUCCESSFULLY "COMPTETED" 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GUIDE CATHETER BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516463 ↗
• MalfunctionOct 25, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN DELIVERING THE STENT INTO THE PATIENT, THE GUIDE CATHETER WAS PULLED OUT THE PUSH CATHETER TO DEPLOY THE STENT, HOWEVER, THE SUTURE DID NOT RELEASE AND THE PUSH CATHETER BROKE. REPORTEDLY, THE STENT WAS IMPLANTED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS BROKEN THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240313 ↗
• MalfunctionSep 14, 2019Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2019-04574). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILIARY DUCT, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, THE SUTURE RELEASED PROPERLY BUT IT FAILED TO DEPLOY. THE DEVICE WAS NOTED TO BE 'DAMAGED'. CANNULATION WAS PERFORMED AND ANOTHER ATTEMPT WAS MADE USING A NEW FLEXIMA BILIARY STENT HOWEVER, THE SAME PROBLEM OCCURRED. FINALLY, A THIRD FLEXIMA BILIARY STENT WAS USED, YET THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING A FOURTH BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE PROXIMAL END OF THE GUIDE CATHETER WAS DETACHED WHILE THE REST OF THE GUIDE CATHETER APPEARED TO HAVE REMAINED WITHIN THE PUSH CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9056529 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR GALLSTONES REMOVAL PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS STUCK AND WAS UNABLE TO 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 AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GUIDE CATHETER BROKE. .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8813282 ↗
• MalfunctionJul 10, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE SUTURE WAS STUCK AND THE STENT WAS UNABLE TO BE DEPLOYED. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT. 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 BROKEN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777151 ↗
• MalfunctionJul 9, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING ENDOSCOPIC MUCOSAL RESECTION (EMR) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT INTO THE COMMON BILE DUCT THROUGH FORCEPS CANA, THE STENT WAS UNABLE TO BE RELEASED CAUSING THE STENT TO BE BROKEN. THE BROKEN STENT WAS REMOVED TOGETHER WITH THE CATHETER. 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 AT THE CONCLUSION OF THE PROCEDURE WAS NOTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771904 ↗
• MalfunctionOct 28, 2018Break; Positioning Failure; Mechanical Problem; Break; Positioning Failure; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREOTOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE TOUHY BOORST WAS UNABLE TO LOOSEN. THEREFORE, THE STENT WAS FAILED TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE GUIDE CATHETER BROKE, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8011393 ↗