NaviFlex™ RX Delivery System M00533580Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729787105), received between Feb 2, 2017 and Sep 23, 2026 — classified as 21 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (38 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 39 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Break

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50873860 ↗
• MalfunctionSep 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599645 ↗
• MalfunctionJul 28, 2026Break; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057608 ↗
• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841660 ↗
• MalfunctionJan 26, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE HEPATIC DUCT FOR A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A 10FR X 10CM DOUBLE PIGTAIL STENT WAS PROPERLY LOADED ONTO THE ADVANIX 10FR DELIVERY SYSTEM AND POSITIONED OVER THE GUIDEWIRE. UPON DEPLOYMENT, THE RADIOPAQUE MARKER ON THE INNER CATHETER OF THE DELIVERY SYSTEM REMAINED WITHIN THE HEPATIC DUCT EVEN AFTER THE GREEN DEPLOYMENT INDICATOR ON THE HANDLE WAS ACTIVATED. THE DISTAL END OF THE INNER CATHETER WAS STILL IN PLACE AND SO THEY NEEDED TO REMOVE THE ENTIRE SYSTEM AND ATTEMPT THE STENT PLACEMENT AGAIN. THEY THEN DECIDED TO PROCEED WITH A DUODENAL BEND "STRAIGHT" STENT INSTEAD OF A DOUBLE PIGTAIL STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183506 ↗
• InjuryJan 9, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE METALLIC STYLET OF THE NAVIFLEX DELIVERY SYSTEM BROKE AFTER STENT PLACEMENT. THE DELIVERY SYSTEM WAS REMOVED, AND THE ORIGINAL STENT REMAINS IMPLANTED 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 24025612 ↗
• InjuryOct 29, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED TO IMPLANT A PLASTIC STENT TO TREAT A BILIARY OBSTRUCTION CAUSED BY STONES IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INTRODUCER FAILED TO FULLY WITHDRAW AND BECAME STUCK IN THE STENT. IT THEN DETACHED FROM THE PULL WIRE SYSTEM, LEAVING THE BLACK INTRODUCER COMPONENT INSIDE THE STENT AND IT WAS REMOVED USING FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414495 ↗
• MalfunctionOct 15, 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 NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE AMPULLA TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, IT WAS REPORTED THAT THE DEVICE WAS BROKEN OR FRACTURED. IT WAS NOTED THAT THE END PART OF THE PUSHER THAT GUIDES THAT STENT WAS FRAYED. SUBSEQUENTLY, THE PUSHER WAS REMOVED THROUGH THE BIOPSY CAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302457 ↗
• InjurySep 11, 2025Break; Positioning Failure; Break; Positioning Failure

  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 FORCEPS. 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 23030696 ↗
• InjuryJul 31, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX STENT WAS IMPLANTED FOR BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER UNLOCKING THE DEVICE AND RETRACTING THE INTRODUCER, THE ASSISTING NURSE NOTED A TACTILE RESPONSE TYPICALLY ASSOCIATED WITH SUCCESSFUL STENT DEPLOYMENT. HOWEVER, VISUAL MONITORING INDICATED THAT THE STENT HAD NOT FULLY SEPARATED FROM THE INTRODUCER. UPON THE PHYSICIAN'S INSTRUCTION TO RETRACT THE SHEATH, THE SHEATH WAS REMOVED, BUT THE INTRODUCER TIP FRACTURED AND REMAINED INSIDE THE PATIENT. ALTHOUGH A RETRIEVAL DEVICE WAS INITIALLY CONSIDERED, THE PHYSICIAN SUCCESSFULLY EXTRACTED THE BROKEN TIP USING THE ELEVATOR. A SUBSEQUENT INSPECTION CONFIRMED THE STENT WAS CORRECTLY POSITIONED, AND NO FURTHER INTERVENTION WAS NECESSARY. THE PROBLEM APPEARED TO INVOLVE THE CATHETER GUIDE WIRE, WHICH PREVENTED THE BLACK INTRODUCER FROM RETRACTING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681343 ↗
• InjuryMay 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 DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BLACK CATHETER REMAINED IN THE PROSTHESIS AFTER DEPLOYMENT. THE DETACHED CATHETER WAS REMOVED USING RAT TOOTH FORCEPS, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056618 ↗
• InjuryFeb 19, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED TO TREAT A COMMON BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS PLACED INTO POSITION FOR DEPLOYMENT, BUT THE GUIDE CATHETER BROKE, AND THE STENT COULD NOT BE DEPLOYED. THE GUIDE CATHETER WAS DETACHED FROM THE HANDLE AND THE OTHER END WAS LEFT IN THE STENT AFTER THE HANDLE WAS WITHDRAWN. SUBSEQUENTLY, A RETRIEVAL FORCEPS WAS USED TO REMOVE THE BROKEN GUIDE CATHETER ALONG WITH THE STENT. ANOTHER NAVIFLEX DELIVERY SYSTEM WAS USED, 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 21411291 ↗
• MalfunctionJan 10, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THE INNER GUIDE CATHETER WAS CRACKED AT THE DISTAL TIP UNDER ENDOSCOPIC VIEW. THE DEVICE WAS REMOVED FROM THE SCOPE, AND IT WAS CONFIRMED THAT THE INNER GUIDE CATHETER WAS CHIPPED. THE STENT FELL INTO THE DUODENOSCOPE, AND THE STENT WAS REMOVED USING FORCEPS. 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 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." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123618 ↗
• MalfunctionNov 26, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH THE NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE BLACK CATHETER SECTION BECAME SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE 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 20787885 ↗
• InjuryNov 26, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX WITH NAVIFLEX RX DELIVERY SYSTEM WAS IMPLANTED TO TREAT A HILAR STRICTURE OF THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE 10FR CENTER BEND ADVANIX STENT WAS PLACED INTO POSITION. THE ASSISTANT PULLED BACK THE BLUE HANDLE TO DEPLOY THE STENT. HOWEVER, WHEN THE HANDLE WAS FULLY RETRACTED, THE BLACK INTRODUCER BROKE AWAY FROM THE DELIVERY SYSTEM AND REMAINED INSIDE THE STENT. THE DELIVERY SYSTEM WAS REMOVED, AND A RAT TOOTH DEVICE WAS USED TO EXTRACT THE BLACK INTRODUCER FROM WITHIN THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784403 ↗
• InjuryNov 21, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH THE NAVIFLEX RX DELIVERY SYSTEM WAS USED TO TREAT A TIGHT HILAR STRICTURE OF THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT, PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A 10FR CENTER-BEND ADVANIX STENT WAS POSITIONED IN THE BILE DUCT. THE ASSISTANT DEPLOYED THE STENT BY PULLING ON THE BLUE HANDLE. ONCE THE HANDLE REACHED ITS MAXIMUM POINT, THEY NOTICED THAT THE INNER GUIDE CATHETER HAD DETACHED FROM THE DELIVERY SYSTEM AND REMAINED INSIDE THE STENT. A RAT-TOOTH FORCEPS WAS USED TO REMOVE THE INNER GUIDE CATHETER FROM THE STENT. THE STENT PLACEMENT WAS MAINTAINED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751896 ↗
• MalfunctionNov 18, 2024Break; Defective Device; Break; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DELIVERY SYSTEM WAS DAMAGED, AND THE STENT COULD NOT BE DEPLOYED. IT IS UNKNOWN WHICH PART OF THE DEVICE WAS DAMAGED, THE NATURE OF THE DAMAGE, AND THE OUTCOME OF 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 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 20714678 ↗
• MalfunctionOct 9, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE ADVANIX NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE AMPULLA TO TREAT A DUODENAL STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDE CATHETER TIP OF THE ADVANIX NAVIFLEX RX DELIVERY SYSTEM BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO AND VIDEO WERE PROVIDED SHOWING THE BLACK INNER GUIDE CATHETER WAS DETACHED AND BENT OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407142 ↗
• InjurySep 4, 2024Break; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation; Break; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE STENT WAS BEING FULLY DEPLOYED, THE INTRODUCER BECAME DETACHED FROM THE PUSH CATHETER. SUBSEQUENTLY, THE INTRODUCER WAS REMOVED USING A RAT-TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH 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 20138585 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX DELIVERY SYSTEM WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BLACK INTRODUCER FAILED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIFLEX DELIVERY SYSTEM. THERE ARE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079201 ↗
• MalfunctionJul 2, 2024Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN DEPLOYING THE STENT. THE NURSE PULLED HARDLY ON THE INNER CATHETER, AND IT BROKE OFF INTO TWO PIECES. A RETRIEVAL DEVICE WAS NOT REQUIRED TO REMOVE THE BROKEN INNER CATHETER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 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 19655887 ↗
• InjuryJun 12, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX DELIVERY SYSTEM RX WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE INNER GUIDE CATHETER WAS DETACHED FROM THE SYSTEM WHEN THE STENT WAS DEPLOYED. THE GUIDEWIRE AND PUSHING CATHETER WERE REMOVED, AND IT WAS NOTED THAT THE BLACK GUIDE CATHETER WAS DETACHED FROM THE PUSHING CATHETER AND REMAINED INSIDE THE STENT. THE BLACK GUIDE CATHETER WAS THEN REMOVED FROM THE PATIENT WITH A RETRIEVAL DEVICE. THE STENT REMAINS IMPLANTED, 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 19525013 ↗
• InjuryMay 14, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED TO IMPLANT A STENT IN THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TIGHT. DURING INSERTION, THE INNER BLACK GUIDE CATHETER BROKE INTO TWO PIECES. THE BROKEN PIECES OF THE GUIDE CATHETER WERE REMOVED USING RAT-TOOTH FORCEPS. 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 BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "PULL BACK ON THE PULL WIRE CAP TO ADJUST THE LENGTH OF THE GUIDE CATHETER IN FRONT OF THE STENT, AND ENGAGE THE NAVIFLEX RX DELIVERY SYSTEM LOCKING MECHANISM. SLIDE THE STENT BARB COVER SO IT IS ON THE DISTAL END OF THE BLUE PUSH CATHETER NEAR THE STENT." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310578 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX DELIVERY SYSTEM WAS TO BE USED DURING A PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE "SNAPPED". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS; HOWEVER, THIS MAY SUGGEST THAT THE GUIDE CATHETER BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055845 ↗
• InjuryMar 7, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE GUIDE CATHETER BROKE OFF. THE BROKEN GUIDE CATHETER WAS REMOVED USING FORCEPS WHILE KEEPING THE STENT IN PLACE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859441 ↗