Flexima™ Biliary M00539220Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08714729162537), received between Jul 30, 2018 and Jan 21, 2026 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Positioning 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 TO TREAT A STENOSIS OF THE UPPER SEGMENT OF BILE DUCT IN THE UPPER SEGMENT OF BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION PRIOR TO THE PROCEDURE, THE STENT WAS ADVANCED ACROSS THE STENOSIS SEGMENT AND DEPLOYED, HOWEVER, THE INNER CORE COULD NOT BE SEPARATED. ANOTHER FLEXIMA BILIARY STENT WAS USED TO 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 WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135757 ↗
• MalfunctionSep 4, 2025Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED TO TREAT A COMMON BILE DUCT STONE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION FOR THE PROCEDURE, THE BARB OF THE STENT FRACTURED DURING UNPACKING, RENDERING THE DEVICE UNUSABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING 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 22974314 ↗
• MalfunctionAug 6, 2025Break; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem; Break; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem

  THIS REPORT PERTAINS TO ONE OF TWO FLEXIMA BILIARY DEVICES USED IN THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 3005099803-2025-03891 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO FLEXIMA BILIARY STENTS WERE ATTEMPTED TO BE IMPLANTED IN THE BILIARY TRACT TO TREAT A BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST FLEXIMA BILIARY STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2025-03891) DID NOT COMPLETELY DEPLOY. THE THREAD THAT HOLDS IT TO THE PUSHER DID NOT RELEASE, REQUIRING FORCEFUL TRACTION, WHICH LED THE DEVICE TO RUPTURE. A SECOND FLEXIMA STENT (SUBJECT OF THIS REPORT) WAS THEN USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE STENTS WERE REMOVED, AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728976 ↗
• MalfunctionAug 6, 2025Break; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem; Break; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem

  THIS REPORT PERTAINS TO ONE OF TWO FLEXIMA BILIARY DEVICES USED IN THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 3005099803-2025-03892 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO FLEXIMA BILIARY STENTS WERE ATTEMPTED TO BE IMPLANTED IN THE BILIARY TRACT TO TREAT A BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST FLEXIMA BILIARY STENT (SUBJECT OF THIS REPORT) DID NOT COMPLETELY DEPLOY. THE THREAD THAT HOLDS IT TO THE PUSHER DID NOT RELEASE, REQUIRING FORCEFUL TRACTION, WHICH LED THE DEVICE TO RUPTURE. A SECOND FLEXIMA STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2025-03892) WAS THEN USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE STENTS WERE REMOVED, AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728140 ↗
• MalfunctionJul 14, 2025Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Break; 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 IN THE COMMON BILE DUCT TO TREAT CBD STONES DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN INTEGRATED BILIARY STENT WAS INTRODUCED VIA DUODENOSCOPE; HOWEVER, THE CONNECTING ROPE FAILED TO DISCONNECT, PREVENTING SUCCESSFUL DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT 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 22502311 ↗
• InjuryJun 19, 2025Break; Positioning Failure; Use of Device Problem; Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Deformation Due to Compressive Stress; 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 BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT RELEASE, IT WAS ELONGATED OVER THE GUIDE, AND WHEN THE STENT WAS ATTEMPTED TO BE REMOVED, THE INTRODUCER ALSO ELONGATED. THE STENT BROKE OVER THE GUIDE, LEAVING THE GUIDE INSIDE THE STENT, WHICH HAD TO BE REMOVED WITH A FOREIGN BODY FORCEPS. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ***06/10/2025 - FERNC15*** 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." THE USER DID NOT FOLLOW THE IFU; THEREFORE, THIS COMPLAINT HAS BEEN ASSIGNED AR CODE 5191: 2457 TO CAPTURE USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294364 ↗
• MalfunctionMay 5, 2025Positioning Failure; Positioning Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO FLEXIMA BILIARY STENTS WERE TO BE IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST STENT (SUBJECT OF THE REPORT 3005099803-2025-02024) DOES NOT ALLOW THE STENT TO BE RELEASED. THE PHYSICIAN THEN REMOVED THE FIRST STENT AND ATTEMPTED TO IMPLANT A SECOND STENT (SUBJECT OF THIS REPORT) BUT THE ISSUE OCCURRED AGAIN, THE STENT WAS NOT RELEASED. BOTH STENTS WERE REMOVED, AND THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN DECIDED THEN TO SUSPEND THE PROCEDURE FOR PROLONGED SURGICAL TIME. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964211 ↗
• MalfunctionMay 5, 2025Positioning Failure; Positioning Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO FLEXIMA BILIARY STENTS WERE TO BE IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST STENT (SUBJECT OF THIS REPORT) DOES NOT ALLOW THE STENT TO BE RELEASED. THE PHYSICIAN THEN REMOVED THE FIRST STENT AND ATTEMPTED TO IMPLANT A SECOND STENT (SUBJECT OF THE REPORT 3005099803-2025-02026) BUT THE ISSUE OCCURRED AGAIN, THE STENT WAS NOT RELEASED. BOTH STENTS WERE REMOVED, AND THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN DECIDED THEN TO SUSPEND THE PROCEDURE FOR PROLONGED SURGICAL TIME. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964209 ↗
• MalfunctionFeb 21, 2025Break; 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 CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A COMMON BILE DUCT STONE DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 21439889 ↗
• MalfunctionApr 30, 2024Break; Positioning Failure; Stretched; Use of Device Problem; Activation, Positioning or Separation Problem; Break; Positioning Failure; Stretched; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS USED TO TREAT A CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED AS THE SUTURE REMAINED CONNECTED AND WAS NOT RELEASED. 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, "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. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS BROKEN INTO TWO PIECES. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214708 ↗
• MalfunctionJun 14, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF OBSTRUCTIVE JAUNDICE DUE TO CANCER OF THE HEAD OF THE PANCREAS, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE STENT WAS BEING PLACED IN THE CORRECT POSITION WITHIN THE BILIARY DUCT, THE TIP OF THE STENT FELL OFF. THE DEVICE 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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 17130234 ↗
• MalfunctionJun 13, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; 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, WHEN THE GUIDE CATHETER WAS PULLED, IT WAS FOUND BROKEN. THE BROKEN GUIDE CATHETER WAS REMOVED IN ONE PIECE AND 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 17122447 ↗
• MalfunctionDec 23, 2022Positioning Failure; Stretched; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Stretched; Material Deformation; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2022-07652 AND MFR. REPORT # 3005099803-2022-07557). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT AND A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERC), BIOPSY, AND PLASTIC BILIARY STENT PLACEMENT PROCEDURE IN THE BILIARY, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, UPON DEPLOYMENT OF THE STENT, WHEN THE GUIDE CATHETER WAS PULLED, THE STENT WOULD NOT DETACH FROM THE GUIDE CATHETER AND FAILED TO DEPLOY. IT WAS NOTICED THAT THE DISTAL PART OF THE GUIDE CATHETER STARTED TO ELONGATE AND HAD TO BE CUT WITH A WIRE CUTTER. THE JAGWIRE GUIDEWIRE WAS ALSO STUCK. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY, INCAN (NATIONAL CANCER INSTITUTE, AND IT WAS UNKNOWN IF THERE WAS AN INTERVENTION NOR IF THERE WAS A PLAN FOR RESCHEDULE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER WAS STRETCHED AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16044131 ↗
• MalfunctionOct 20, 2022Break; Break

  IT WAS REPORTED THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE INTEGRATED BILIARY STENT WAS PLACED NORMALLY, THE INNER CORE BROKE IN THE STENT. AFTER THAT, ANOTHER NEW BRACKET WAS REPLACED. THE EVENT PROLONGED THE OPERATION TIME AND INCREASED THE OPERATION RISK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 25, 2022, AND OCTOBER 27, 2022: EVENT INFORMATION: THE INNER CORE OF THE GUIDE CATHETER WAS FOUND BROKEN, OUTSIDE THE PATIENT. DEVICE OUTCOME: UNABLE TO USE. OUT OF BOX ISSUE. PROCEDURE OUTCOME: PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILLARY STENT. PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15637868 ↗
• MalfunctionSep 19, 2022Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMABILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, 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. INVESTIGATION RESULTS REVEALED 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 15444745 ↗
• MalfunctionFeb 24, 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 PROCEDURE, IT WAS NOTED THAT IMPLANTATION OF A FLEXIMA BILIARY STENT WAS NEEDED DUE TO THE TUMOR. THEY FOLLOWED THE INSTRUCTIONS AND WERE ABLE TO POSITION THE FLEXIMA BILIARY STENT IN THE CHANNEL; HOWEVER WHEN A RELEASE WAS PERFORMED, THEY COULD NOT RELEASE IT SUCCESSFULLY. IT WAS FOUND THAT THE FLEXIMA BILIARY STENT BECAME BROKEN DUE TO HOW MUCH EFFORT HAD BEEN EXERTED. 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 13592645 ↗
• MalfunctionFeb 23, 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 PROCEDURE, IT WAS NOTED THAT IMPLANTATION OF A FLEXIMA BILIARY STENT WAS NEEDED DUE TO THE TUMOR. THEY FOLLOWED THE INSTRUCTIONS AND WERE ABLE TO POSITION THE FLEXIMA BILIARY STENT IN THE CHANNEL; HOWEVER WHEN A RELEASE WAS PERFORMED, THEY COULD NOT RELEASE IT SUCCESSFULLY. IT WAS FOUND THAT THE FLEXIMA BILIARY STENT BECAME BROKEN DUE TO HOW MUCH EFFORT HAD BEEN EXERTED. 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 13585310 ↗
• MalfunctionFeb 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 COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE GUIDE CATHETER COULD NOT BE REMOVED. ANOTHER FLEXIMA BILIARY URETERAL 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 DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13530553 ↗
• MalfunctionNov 30, 2021Break; Positioning Failure; Deformation Due to Compressive Stress; Break; Positioning Failure; Deformation Due to Compressive Stress

  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) 2021. DURING PROCEDURE, WHEN THE PROCEDURE WAS ALMOST DONE, THE FLEXIMA BILIARY STENT "STUCKED" OVER THE GUIDEWIRE AND THE PUSHER. 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. 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 12889053 ↗
• MalfunctionOct 28, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  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, 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. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER WAS SLIGHTLY KINKED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713004 ↗
• MalfunctionOct 19, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA PLUS BILIARY STENT WAS USED DURING A PROCEDURE. THE EVENT DATE WAS NOT REPORTED. IT WAS REPORTED THAT THEY HAVE A PROBLEM DEPLOYING THE STENT AND THAT THE GUIDE CATHETER WAS STRETCHED UNTIL IT BECAME BROKEN. THERE WERE NO INFORMATION AVAILABLE TO THE PROCEDURE OUTCOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS 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 12661031 ↗
• MalfunctionAug 31, 2021Break; Positioning Failure; Stretched; Break; Positioning Failure; Stretched

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE GUIDE CATHETER WAS STRETCHED UNTIL IT BROKE AND STENT FAILED TO DEPLOY. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO KNOW PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391510 ↗
• MalfunctionJul 29, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION 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 IT WAS BLOCKED AND 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 12245448 ↗
• 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 THREE 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 11686941 ↗
• MalfunctionFeb 19, 2021Break; Positioning Failure; Break; Positioning Failure

  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) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK THE GUIDE CATHETER TO POSITION THE STENT, THE GUIDE CATHETER WAS RIPPED OFF. REPORTEDLY, THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ENABLING THE DEVICE 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11354374 ↗