NavienTM RFX072-115-08MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00847536017924), received between Sep 26, 2018 and Aug 13, 2026 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (17 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem; Packaging Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236643 ↗
• MalfunctionApr 15, 2026Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH UNKNOWN DIAMETER. IT WAS REPORTED THAT IMMEDIATELY AFTER TAKING THE NAVIEN CATHETER OUT, MID-SECTION DAMAGE WAS NOTICED. A NEW ONE WAS USED INSTEAD TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED. ANEURYSM CHARACTERISTICS WERE UNKNOWN. A KINK WAS OBSERVED IN THE CATHETER WHEN IT WAS REMOVED FROM THE PACKAGING. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889127 ↗
• MalfunctionJan 29, 2026Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT UPON REMOVING THE NAVIEN CATHETER FROM ITS PACKAGING, A KINK WAS DISCOVERED IN THE DISTAL END. THE PRODUCT WAS REPLACED WITH A NEW NAVIEN CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 8 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE KINK WAS NOT DETERMINED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DEVICE PACKAGING WAS NOT DAMAGED ON DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218576 ↗
• MalfunctionJan 28, 2026Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A NAVIEN WAS FOUND KINKED CAUSING THE ECHELON CATHETER DIFFICULTY TO ADVANCE. THE PATIENT WAS UNDERGOING AN ANEURYSM EMBOLIZATION. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.8 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE OPERATOR USED A NAVIEN AND ECHELON CATHETER. AFTER THE NAVIEN CATHETER ENTERED THE BODY, RESISTANCE WAS FELT WHEN ADVANCING THE TIP, MAKING IT DIFFICULT TO POSITION. AFTER FINALLY PLACING IT, AN ECHELON MICROCATHETER COULD NOT BE ADVANCED TO THE ANEURYSM WITHIN THE NAVIEN. BOTH THE NAVIEN AND ECHELON WERE THEN WITHDRAWN TOGETHER, AND IT WAS FOUND THAT THE TIP OF THE NAVIEN WAS KINKED. THE NAVIEN WAS REPLACED WITH A NEW ONE, WHILE THE SAME ECHELON MICROCATHETER WAS USED. THIS TIME, THE ECHELON WAS ABLE TO REACH THE TARGET SMOOTHLY, AND THE PROCEDURE CONTINUED WITH COIL EMBOLIZATION. THE OPERATION WAS SUCCESSFUL, AND THE PATIENT WAS UNHARMED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202786 ↗
• InjuryJan 13, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD MULTIPLE INTRACRANIAL ANEURYSMS OF THE RIGHT INTERNAL CAROTID ARTERY, INCLUDING A LARGE 10MM ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY SEGMENT AND A SMALL 4MM ANEURYSM AT THE OPHTHALMIC ARTERY SEGMENT. THE OPERATOR PLANNED TO IMPLANT A PIPELINE FOR TREATMENT. DURING THE PROCEDURE TO ESTABLISH ACCESS, IT WAS FOUND THAT THE MICROCATHETER COULD NOT ENTER THE LUMEN OF THE NAVIEN DUE TO SIGNIFICANT RESISTANCE. AFTER REPLACING WITH A NEW ONE, IT WENT THROUGH SUCCESSFULLY. THE MARKSMAN MICROCATHETER WAS POSITIONED, AND A PED-450-30 WAS DELIVERED TO THE DISTAL END OF THE MICROCATHETER. HOWEVER, THE STENT COULD NOT BE CAME OUT DESPITE BEING ABLE TO BE RETRIEVED. MULTIPLE ATTEMPTS WERE MADE WITH INCREASED PUSHING FORCE, BUT THE PROBLEM PERSISTED. SUBSEQUENTLY, POSSIBLY DUE TO REPEATED FORCEFUL MANIPULATION, THE ANEURYSM SUDDENLY RUPTURED DURING THE PROCEDURE. THE OPERATOR STATED THAT THE STENT HAD A QUALITY ISSUE AND WOULD NOT BE CHARGED FOR IT. THE DEVICE WAS STUCK (LOCKED UP) IN THE CATHETER/RESISTANCE IN THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PIPELINE BECAME STUCK IN THE DISTAL SECTION OF THE C

  Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions; Ruptured Aneurysm

  MAUDE report 24060650 ↗
• MalfunctionDec 17, 2025Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATOR PERFORMED A DENSE MESH FLOW-DIVERTING STENT IMPLANTATION PROCEDURE USING THE PIPELINE FLEX. THE SYSTEM WAS SUCCESSFULLY POSITIONED AND DEPLOYED BELOW TO THE T-BIFURCATION. HOWEVER, WHEN DEPLOYED IT TO THE PROXIMAL END, THE SYSTEM SLIPPED TOWARD THE PROXIMAL ASPECT OF THE ANEURYSM WHILE UNSHEATHING UNDER REDUCED TENSION. THE OPERATOR ADVANCED AN INTERMEDIATE CATHETER AND GUIDED THE SYSTEM INTO THE MIDDLE CEREBRAL ARTERY TO REDEPLOY THE STENT. NEVERTHELESS, THE STENT COULD NOT BE DEPLOYED AT THE PROXIMAL MARKER. THE SYSTEM WAS REMOVED FROM THE BODY, AND IT WAS SUSPECTED THAT THE STENT HAD BECOME STUCK WITH THE MICROCATHETER. A NEW PHENOM 27 WAS ADVANCED, AND A NEW PED-375-20 DENSE MESH FLOW-DIVERTING STENT WAS USED. IT WAS DEPLOYED SUCCESSFULLY AT THE INTENDED LOCATION, AND THE PROCEDURE WAS COMPLETED SMOOTHLY. THE PATIENT EXPERIENCED NO ADVERSE REACTIONS. THE PIPELINE BECAME STUCK AT THE HUB DURING DEPLOYMENT. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISS UE, BUT THE ISSUE DID NOT RESOLVE. CATHETER RESISTANCE IN THE DISTAL SECTION WAS REPORTED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827984 ↗
• MalfunctionDec 10, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER PUNCTURING AND PLACING THE SHEATH, THE SURGEON EXCHANGED THE SUPPORT CATHETER AND REMOVED THE RADIAL SHEATH. HE THEN USED THE SUPER-SMOOTH GUIDE WIRE TO GUIDE THE NAVIEN SUPPORT CATHETER DIRECTLY TO THE C3 SEGMENT OF THE INTERNAL CAROTID ARTERY. AFTER THE STENT MICROCATHETER WAS IN PLACE, HE PLACED THE ECHELON MICROCATHETER AND FOUND THAT THE INTERMEDIATE CATHETER COULD NOT BE DELIVERED. THE GUIDEWIRE WAS THEN WITHDRAWN AND THE ECHELON MICROCATHETER DELIVERY WAS ATTEMPTED, BUT DELIVERY WAS STILL UNSUCCESSFUL. AFTER ALL SYSTEMS WERE WITHDRAWN, IT WAS DISCOVERED THAT THE MIDDLE SECTION OF THE TERMINAL CATHETER WAS SEVERELY KINKED. THE SURGEON THEN ATTEMPTED TRANSRADIAL TREATMENT USING A HIGH-PERFORMANCE LONG SHEATH BUT WAS UNSUCCESSFUL, AND THE FEMORAL ARTERY WAS RE-PUNCTURED FOR TREATMENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE CATHETER WAS KINKED IN THE MIDDLE. THE PATIENT IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOING SURGERY FOR TRANSRADIAL ARTERY ANEURYSM EMBOLIZATION TREATMENT. THE ACCESS VESSEL WAS AFTER RADIAL ARTERY, FEMORAL ARTERY. IT WAS NOTED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773419 ↗
• MalfunctionOct 22, 2025Break; Collapse; Fracture; Physical Resistance/Sticking; Break; Collapse; Fracture; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE SMALL CRACK WAS AT THE TIP OF THE CATHETER LOCATED AT THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360405 ↗
• MalfunctionAug 15, 2025Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813749 ↗
• MalfunctionJul 21, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 5.62MM DIAMETER. IT WAS REPORTED THAT DURING THE ANEURYSM SURGERY, THE SURGEON USED A NAVIEN CATHETER, THE TIP OF WHICH WAS BROKEN, AND THEN REPLACED IT WITH A CATHETER OF THE SAME MODEL TO CONTINUE THE SURGERY, AND THE PATIENT WAS FINE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556605 ↗
• MalfunctionMay 30, 2025Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED REPORTED THE NAVIEN INTERMEDIATE CATHETER WAS NO INVOLVED IN THE REPORTED EVENT OF THE "THE SYSTEM S LIPPED AS A WHOLE"; THERE WAS NO ISSUE WITH THE NAVIEN. IT WAS INDICATED THAT THE PIPELINE WAS DELIVERED AROUND THE POSTERIOR COMMUNICATING ARTERY AT THE FURTHER POSSIBLE POINT AND SLIPPED/JUMPED DURING DEPLOYMENT. THE CAUSE WAS NOT DETERMINED BUT CONSIDERED POSSIBLY DUE TO RESISTANCE OR TO THE PATIENT'S VESSEL TORTUOSITY AND MODEL/SIZE OF THE PIPELINE STENT. ONE PIPELINE WAS BEING USED AT THE TIME OF THE EVENT. THE TIP OF THE MARKSMAN CATHETER WAS MOVED DURING PIPELINE DEPLOYMENT. BASED ON ADDITIONAL INFORMATION RECEIVED ON 18JUN2025, THE NAVIEN CATHETER DEVICE IS NO LONGER CONSIDERED A COMPLAINT OR REPORTABLE. MDR DECISION CORRECTED TOO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDR'S ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117554 ↗
• MalfunctionApr 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT FOR THE RUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY C6 SEGMENT, THE BLOOD FLOW DIVERSION DENSE MESH STENT PED-475-20, LOT NUMBER: B709537, WAS SELECTED TO IMPLANT. DURING THE DEPLOYMENT PROCESS, THE TAIL END OF THE STENT COULD NOT OPEN NORMALLY. BECAUSE THE TAIL END OF THE STENT COULD NOT OPEN, THE STENT WAS RETRIEVED AND DEPLOYED AGAIN, BUT IT WAS FOUND THAT THE STENT COULD NOT BE RETRIEVED, AND THEN THE WHOLE SYSTEM WAS REMOVED FROM THE BODY. THERE WAS FAILURE TO OPEN IN THE PROXIMAL SECTION. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT C6 ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE WAS 3.5 MM DISTAL AND 4.9 MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WAS NORMAL POSTOPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895946 ↗
• MalfunctionApr 3, 2025Collapse; Collapse

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIEN CATHETER THAT WAS DAMAGED. THE PATIENT WAS UNDERGOING AN EMERGENCY THROMBECTOMY PROCEDURE VIA FEMORAL ACCESS TO TREAT A LARGE VESSEL OCCLUSION. PATIENT VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT AFTER OPENING, IT WAS OBSERVED THAT THE DISTAL NAVIEN CATHETER TIP WAS CRUSHED. THE DAMAGED CATHETER WAS REPLACED WITH A NEW ONE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DAMAGE WAS NOT NOTICED UPON OPENING THE PACKAGE. ROUTINE SURGICAL PROCEDURES WERE PERFORMED BEFORE IT WAS OBSERVED. THE DEVICE WAS USED AT ALL IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763064 ↗
• MalfunctionFeb 13, 2025Difficult to Advance; Unintended Movement; Physical Resistance/Sticking; Difficult to Advance; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM IN THE HORIZONTAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY, AND THE SURGEON PLANNED TO TREAT IT WITH A DENSE MESH STENT PIPELINE + COIL. THE SURGERY BEGAN WITH ESTABLISHING AN ACCESS, PUSHING A 6FNAVIEN, AND PLANNING TO INSERT A MARKSMAN AND ECHELON IN PARALLEL WITH THE NAVIEN. IN ACTUAL OPERATION, AFTER THE 6FNAVIEN REACHED THE OPHTHALMIC ARTERY, IT COULD NOT BE PUSHED UP ANY FURTHER AND STABILIZED AT THE HORIZONTAL SEGMENT OF THE CAVERNOUS SINUS. SO THE SURGEON CHANGED THEIR STRATEGY AND DELIVERED THE MARKSMAN, ENCOUNTERING RESISTANCE IN THE DISTAL SECTION DURING THE DELIVERY PROCESS. AFTER FINALLY RAISING THE MARKSMAN UP TO M2, WHEN DELIVERING THE ECHELON, THE MARKSMAN TIP WAS UNSTABLE AND FELL OFF AGAIN. THE SURGEON REPEATED OPERATIONS TWICE AND FOUND THAT THE MARKSMAN AND ECHELON WERE UNSTABLE IN THE NAVIEN. IN ORDER TO PREVENT ACCIDENTS WHEN DEPLOYING THE PIPELINE LATER, THE SURGEON REPLACED IT WITH A NEW MICROCATHETER PHENOM27 AND 5FNAVIEN, RE-PUNCTURED ON THE LEFT SIDE, PUNCTURED BOTH SIDES, DEPLOYED THE PIPELINE ON ONE SIDE, AND FILLED THE COIL ON THE OTHER SIDE TO TREAT THE ANEURYSM. THE REPORTED DEVICES AND ANY AC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375921 ↗
• MalfunctionFeb 6, 2025Break; Collapse; Difficult to Advance; Material Deformation; Break; Collapse; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A CAROTID ARTERY STENOSIS PROCEDURE, THE DSC 6F X 115CM US CATHETER EXPERIENCED SIGNIFICANT BENDING WHILE ATTEMPTING TO ESTABLISH ACCESS THROUGH THE FEMORAL ARTERY, WHICH HAD A DIAMETER OF 5.5MM AND MODERATE VESSEL TORTUOSITY. THE CATHETER TRIED TO GO UPPER MANY TIMES BUT FAILED WHEN ESTABLISHED ACCESS. THE CATHETER WAS CRUSHED, KINKED, AND DAMAGED AT THE PROXIMAL LOCATION. AS A RESULT, THE CATHETER WAS REMOVED FROM THE BODY AND REPLACED WITH A NEW ONE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE WAS UNDETERMINED. WHEN IT WAS WITHDRAWN FROM THE BODY, IT WAS A RUPTURED STA TE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21325198 ↗
• MalfunctionJan 17, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIEN CATHETER THAT HAD RESISTANCE AT THE DISTAL END AND WAS OBSERVED TO BE DAMAGED. THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE VIA FEMORAL ACCESS. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE NAVIEN CATHETER AND ALL ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WITH THE REBAR MICROCATHETER AT THE DISTAL END OF THE NAVIEN CATHETER. THE RESISTANCE WAS SEVERE. WHEN THE SYSTEM WAS REMOVED FROM THE PATIENT'S BODY, THE PROXIMAL END OF THE NAVIEN CATHETER WAS FOUND TO BE FLATTENED. THE NAVIEN WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE AS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. 2025-01-12 E1, COMM (REP, HCP, FOR): NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180205 ↗
• MalfunctionJul 26, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING STENT-ASSISTED SPRING COIL EMBOLIZATION, FLUID LEAKED FROM THE TIP OF THE ECHELON MICROCATHETER WHEN FLUSHING THE MICROCATHETER. THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION. THERE WERE CREASES AT THE DISTAL END OF THE NAVIEN. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR STENT-ASSISTED ANEURYSM EMBOLIZATION. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 20MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844507 ↗
• MalfunctionJun 11, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE CATHETER WAS TAKEN OUT AND HYDRATED, THE TIP OF THE CATHETER WAS FOUND TO BE DAMAGED WHEN IT WAS PLANNED TO INTRODUCE THE GUIDING CATHETER. HEALTHCARE PROVIDER (HCP) WAS WORRIED THAT IT WOULD AFFECT THE CATHETER'S ABILITY TO GO UPPER AND SUBSEQUENT PASSAGE OF THE MICROCATHETER. AFTER REPLACING WITH A CATHETER, THE SURGERY WENT SMOOTHLY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING ANEURYSM PED IMPLANTATION SURGERY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513324 ↗
• MalfunctionApr 22, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DAMAGE WAS NOT NOTICED UPON OPENING THE PACKAGE. NO PREPARATION WAS PERFORMED PRIOR TO THE DAMAGE BEING SEEN. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152416 ↗
• MalfunctionFeb 21, 2024Patient-Device Incompatibility; Difficult to Advance; Material Deformation; Material Integrity Problem; Patient-Device Incompatibility; Difficult to Advance; Material Deformation; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THE NAVIEN CATHETER WAS FOUND TO HAVE DIFFICULT NAVIGATION, A KINK, AND SOME COATING HAD FALLEN OFF. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE RADIAL ARTERY WITH A DIAMETER OF 4.1 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE SURGEON PERFORMED SURGERY THROUGH THE RADIAL ARTERY AND PUSHED NAVIEN CATHETER TO GO UP, BUT FOUND THAT IT COULD NOT ENTER THE INTERNAL CAROTID ARTERY SMOOTHLY. AFTER REPEATED OPERATIONS, IT STILL COULD NOT BE IN PLACE. AFTER WITHDRAWING, IT WAS FOUND THAT ASECTION OF THE DISTAL END OF THE CATHETER WAS CREASED, AND THE COATING SEEMED TO HAVE FALLEN OFF THE SURFACE. AFTER THE SURGEON REPLACED OTHER PRODUCT, THE SURGERY WAS SUCCESSFULLY COMPLETED. THE SURGEON THOUGHT IT HAD A PRODUCT QUALITY PROBLEM AND REQUIRED IT TO BE RETURNED. PLEASE IDENTIFY IT. IT WAS REPORTED THERE WAS A CATHETER KINK IN THE DISTAL SECTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748758 ↗
• MalfunctionOct 26, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE INTERVENTIONAL TREATMENT OF THE ANEURYSM, THE SURGEON USED A MICROCATHETER TO GUIDE THE INTERMEDIATE CATHETER TO BE PUSHED TO GO UPPER. IT WAS FOUND THAT THE INTERMEDIATE CATHETER WAS KINKED IN THE DISTAL PORTION AND THE INTERMEDIATE CATHETER COULD NOT BE PUSHED TO GO UPPER. AFTER IT WAS WITHDRAWN FROM THE BODY, IT WAS VISIBLE TO THE NAKED EYE THAT THE TUBE BODY HAD OBVIOUS FRACTURES. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR INTERVENTIONAL TREATMENT OF AN ANEURYSM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 4.5MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013723 ↗
• MalfunctionAug 30, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE TIP END OF THE INTERMEDIATE CATHETER WAS BROKEN. THE CATHETER WAS KINKED AT THE DISTAL END. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR NARROW TREATMENT. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE AN UNKNOWN SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655119 ↗
• MalfunctionFeb 10, 2023Break; Material Deformation; Break; Material Deformation

  NEW INFORMATION WAS RECEIVED THAT THE CAUSE OF THE CATHETER SEPARATION/BREAK/DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353961 ↗
• MalfunctionJan 13, 2023Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT AFTER UNPACKING THE NAVIEN CATHETER FOR USE, THE SURGEON FOUND THAT THE MIDDLE OF THE CATHETER WAS BROKEN SO IT WAS REPLACED WITH A NEW NAVIEN CATHETER FOR THE PROCEDURE.  IT WAS NOTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MIDDLE SECTION WAS KINKED, BUT NOT FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162541 ↗
• MalfunctionNov 2, 2022Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL TIP OF THE NAVIEN CATHETER WAS FOUND TO BE DEFORMED. THE THROMBECTOMY WAS PERFORMED FROM THE RING ENCAPSULATOR. THE CATHETER WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN INTRACRANIAL ANEURYSM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN ANEURYSM. THE NURSE IN THE CATHETERIZATION LAB OPENED IT NORMALLY WITHOUT ANY ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE DAMAGE NOTICED UPON OPENING THE PACKAGE. THERE ANY DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715270 ↗