NaviFlex™ RX Delivery System M00533560Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 08714729787082), received between Mar 23, 2017 and Sep 30, 2026 — classified as 50 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Break” (107 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955152 ↗
• MalfunctionMay 22, 2026Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE END CAP OF THE DELIVERY SYSTEM BROKE UPON DEPLOYMENT OF THE STENT. THE STENT WAS DEPLOYED AS INTENDED; HOWEVER, THE DELIVERY SYSTEM FRACTURED DURING DEPLOYMENT. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260042 ↗
• InjuryFeb 10, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE WHILE THE STENT WAS BEING DEPLOYED, RESULTING IN A PORTION OF THE DEVICE REMAINING INSIDE THE PATIENT. THE BROKEN GUIDE CATHETER WAS REMOVED USING RAT TOOTH FORCEPS. ANOTHER NAVIFLEX DELIVERY SYSTEM WAS THEN USED TO SUCCESSFULLY 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 24309799 ↗
• MalfunctionOct 23, 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 NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) WITH STENT IMPLANT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE INNER SHEATH OF THE DEVICE WAS SEPARATED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367090 ↗
• InjuryOct 20, 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 NAVIFLEX RX DELIVERY SYSTEM WAS USED TO TREAT CHOLANGIOCARCINOMA STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TIGHT PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEPLOYMENT SYSTEM BROKE, LEAVING THE INTRODUCER IN THE STENT. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342370 ↗
• InjurySep 11, 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 AN ADVANIX-NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILIARY SITE TO TREAT BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER SHEATH BROKE AND WAS REMOVED USING SNARES. ANOTHER NAVIFLEX DELIVERY SYSTEM 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 23029881 ↗
• MalfunctionSep 4, 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 AN ADVANIX-NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT COMMON BILE DUCT STENOSIS IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS ABOUT TO DEPLOY THE STENT AT THE LESION SITE, THE DELIVERY SYSTEM FRACTURED, RESULTING IN THE FAILURE OF STENT DEPLOYMENT. THE ISSUE WAS NOTICED DURING WITHDRAWAL, AND THE PROBLEM OCCURRED INSIDE THE PATIENT. ANOTHER ADVANIX-NAVIFLEX RX DELIVERY SYSTEM 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. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." 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 22974319 ↗
• InjurySep 4, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED TO THE COMMON BILE DUCT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NAVIFLEX INNER SHEATH MOVED EVEN IN LOCKED MODE. IN THE PROCESS OF TAKING THE STENT OUT OF THE BODY, THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968432 ↗
• MalfunctionSep 3, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED TO THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NAVIFLEX GUIDE CATHETER MOVED EVEN IN LOCKED MODE, AS IT WAS REPORTEDLY BROKEN. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING 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 NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "TO DEPLOY THE STENT, LOOSEN THE TUOHY-BORST ADAPTER SLIGHTLY AND PULL ON THE GUIDE CATHETER LUERLOK HUB AND GUIDEWIRE. HOLD THE OUTER POSITIONER STATIONARY, WHILE GENTLY RETRACTING THE INNER GUIDE CATHETER AND GUIDEWIRE. ENDOSCOPICALLY MONITOR THE STENT POSITION. WARNING IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED. THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22958029 ↗
• InjuryJul 11, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT STRICTURES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH INTRAHEPATIC STENT PLACEMENT PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ADVANIX STENT WOULD NOT COME OFF THE GUIDE CATHETER, AND THE GUIDE CATHETER WAS STILL COMPLETELY INSIDE THE STENT DESPITE THE WIRE BEING FULLY DEPLOYED. A RESCUE FORCEPS WAS USED TO PULL THE GUIDE CATHETER OUT OF THE STENT, AND THE GUIDE CATHETER WAS COMPLETELY DETACHED FROM THE DEPLOYMENT HUB CATHETER. THE GUIDE CATHETER WAS REMOVED USING RESCUE FORCEPS, AND A DIFFERENT STENT WAS PLACED ON THE OTHER SIDE 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 22481196 ↗
• MalfunctionJul 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 NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED FOR A STENT IMPLANT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE DURING DEPLOYMENT. AS A RESULT, THE PROCEDURE WAS CANCELLED. HOWEVER, THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ALLOWING THE ENTIRE DELIVERY SYSTEM TO BE REMOVED AS A SINGLE UNIT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22397344 ↗
• MalfunctionMay 22, 2025Break; Device Difficult to Setup or Prepare; Material Deformation; Break; Device Difficult to Setup or Prepare; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED (B)(6) 2025. IT WAS REPORTED THAT THERE WERE DEFECTS CONNECTING THE NAVIFLEX DELIVERY SYSTEM WITH THE ADVANIX STENT. ANOTHER OF THE SAME 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 AND PULL WIRE WERE BROKEN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071231 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED TO TREAT STONE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE AND PERFORMED ON (B)(6) 2025. DURING STENT PREPARATION, IT WAS OBSERVED THAT THE BLACK INTRODUCER OF THE NAVIFLEX RX DELIVERY SYSTEM DID NOT MOVE WHEN THE DEPLOYMENT WIRE WAS PULLED. IT WAS NOTED THAT A BREAK OCCURRED. THE PROCEDURE WAS COMPLETED USING THE ORIGINALLY INTENDED STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061710 ↗
• InjuryMay 8, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER SHEATH SEPARATED FROM THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982422 ↗
• MalfunctionMay 5, 2025Break; Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PULL WIRE CAP OF THE NAVIFLEX DELIVERY SYSTEM POPPED OFF, AND THE GUIDE CATHETER AND PULL WIRE WERE KINKED AND BROKEN. HEMOSTATS WERE USED TO FINISH THE DEPLOYMENT, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964033 ↗
• InjuryApr 25, 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 AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE DISTAL COMMON BILE DUCT TO TREAT A PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ADVANIX STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE GUIDE CATHETER WAS DETACHED WHEN THE NAVIFLEX DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. THE DETACHED GUIDE CATHETER WAS REMOVED USING RAT TOOTH FORCEPS BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN USED AN EXTRACTION BALLOON, AND THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. 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 ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "FOR PRELOADED SYSTEM ONLY: IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE ENDOSCOPE, THE STENT CAN NOT BE FULLY DEPLOYED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914472 ↗
• InjuryMar 28, 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 AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER SHEATH WAS SEPARATED DURING DEPLOYMENT. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724086 ↗
• InjuryMar 28, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER SHEATH WAS SEPARATED DURING DEPLOYMENT. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON MARCH 27, 2025: IT WAS REPORTED THAT THE ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILIARY DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE. THE DETACHED BLACK INNER SHEATH WAS REMOVED USING A SNARE AND ANOTHER NAVIFLEX DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724085 ↗
• InjuryMar 20, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILIARY DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE CATHETER DETACHED AND WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER NAVIFLEX DELIVERY SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655099 ↗
• InjuryMar 18, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX WAS IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER SHEATH OF THE NAVIFLEX RX DELIVERY SYSTEM GOT SEPARATED FROM THE OUTER SHEATH. THE DETACHED INNER SHEATH WAS REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX-NAVIFLEX DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638572 ↗
• InjuryMar 18, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX WAS IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER SHEATH OF THE NAVIFLEX RX DELIVERY SYSTEM GOT SEPARATED FROM THE OUTER SHEATH. THE DETACHED INNER SHEATH WAS REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX-NAVIFLEX DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638571 ↗
• InjuryMar 12, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED FOR STENT PLACEMENT IN THE COMMON BILE DUCT TO TREAT A BENIGN STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE INTO TWO PIECES DURING RELEASE. THE BROKE GUIDE CATHETER WAS REMOVED WITH GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587808 ↗
• InjuryMar 3, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX NAVIFLEX RX WITH DELIVERY SYSTEM WAS IMPLANTED TO TREAT STONES IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON FEBRUARY 4, 2025. DURING THE PROCEDURE, WHEN THE ADVANIX STENT WAS PLACED, THE INTRODUCER BROKE. THE END PIECE THAT SUPPORTS THE STENT BECAME DISCONNECTED FROM THE REST OF THE INTRODUCER. A FRAGMENT OF THE INTRODUCER WAS NOTICED TO BE INSIDE THE STENT AND WAS SUBSEQUENTLY REMOVED USING RAT TOOTHS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE ADVANIX NAVIFLEX 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 AR CODE 5191:2457 (USE OF DEVICE ISSUE - USER ERROR) HAS BEEN APPLIED. THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505967 ↗
• MalfunctionFeb 4, 2025Break; Use of Device Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER THE PHYSICIAN REPLACED THE LESION, THEY TRIED TO DEPLOY THE STENT BUT COULD NOT BECAUSE THE INNER SHEATH DID NOT MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309677 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX WAS USED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, IT WAS NOTED THAT THE STYLET CAME AWAY FROM THE CATHETER AND IT REMAINED INSIDE THE PATIENT AFTER THE STENT WAS DEPLOYED, THE CATHETER WAS THEN REMOVED USING A RAT TOOTH. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114461 ↗