REACT™ REACT-71Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00847536044197), received between Jun 16, 2022 and Jan 23, 2026 — classified as 5 deaths, 16 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Difficult to Remove; Stretched; Difficult to Advance

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PROCESS OF WITHDRAWING THE CATHETER WAS RELATIVELY SMOOTH. THE CAUSE OF THE RESI STANCE/DIFFICULT NAVIGATION WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160767 ↗
• MalfunctionNov 18, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE MARKER BAND DISLODGEMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584108 ↗
• MalfunctionSep 25, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE REACT CATHETER WAS KINKED AND RESISTANCE WAS FELT DURING WITHDRAWAL. THE PATIENT WAS UNDERGOING TREATMENT FOR A PLAQUE IN THE PROXIMAL SECTION OF THE RIGHT CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO CALCIFICATION. THERE WAS CHRONIC TOTAL OCCLUSION. THE PATIENT WAS ADMITTED TO THE EMERGENCY HOSPITAL WITH LEFT LIMB IMMOBILITY AND DIAGNOSED WITH ACUTE CEREBRAL INFARCTION. IT WAS REPORTED THAT A BALLOON GUIDE CATHETER WAS USED FOR PROXIMAL SUPPORT, AND A NON-MEDTRONIC GUIDEWIRE AND MICROCATHETER WERE THEN USED TO ADVANCE THROUGH THE LESION AND REACH THE DISTAL LESION. THE MICROCATHETER REACHED BEYOND THE PETROUS VALLECULA OF THE INTERNAL CAROTID ARTERY. MANUAL ANGIOGRAPHY CONFIRMED THAT THE MICROGUIDEWIRE AND MICROCATHETER WERE IN THE TRUE LUMEN AND THAT DISTAL BLOOD FLOW WAS UNOBSTRUCTED. IT WAS SUSPECTED THAT THE PATIENT'S LIMB IMMOBILITY WAS CAUSED BY A PROXIMAL ORIGIN OCCLUSION, AND RECANALIZATION OF THE ORIGIN VESSEL WAS PLANNED. THE GUIDEWIRE WAS REMOVED AND EXCHANGED WITH ANOTHER GUIDEWIRE, AND A 5 EMBOLIC PROTECTION DEVICE WAS PLANNED FOR DISTAL PROTECTION. AFTER REMOVING THE EMBOLIC PROTECTION DE

  Patient problems: Ischemia

  MAUDE report 23144753 ↗
• MalfunctionSep 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT ONLY ONE SFR STENT WAS USED, DESPITE THE MPXR INDICATING A "SET OF STENTS" BEING RETURNED. THE ALLEGED ISSUE WAS SUSPECTED DEFORMATION NEAR THE DETACHMENT POINT; HOWEVER, THERE WAS NO BREAK OR SEPARATION OBSERVED. THERE WERE NO ISSUES DURING NAVIGATION OF THE MICROCATHETER, AND CATHETER FLUSH WAS ADMINISTERED PER IFU. THE FIRST PASS SUCCESSFULLY REACHED THETHROMBUS, AND NO FRICTION WAS ENCOUNTERED DURING DELIVERY ON EITHER THE FIRST OR SECOND PASS. NO KINK OR DAMAGE WAS OBSERVED ON THE CATHETER. IT WAS UNCLEAR IF THERE WAS ANY KINK OR DAMAGE ON THE PUSHWIRE OF THE SOLITAIRE. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER. THE REACT-71 CATHETER WAS NOT USED FOR ANGIOGRAPHY BUT WAS USED AS A SUCTION AND SUPPORT CATHETER DURING SFR STENT DELIVERY, WITH A MICROCATHETER INSIDE AND THE THROMBECTOMY STENT INSIDE THE MICROCATHETER. THE CAUSES OF BOTH RESISTANCE AND DEFORMATION WERE NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042307 ↗
• MalfunctionJul 21, 2025Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER TIP WAS STRETCHED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556298 ↗
• MalfunctionJul 7, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE SURGEON PUSHED REACT71 INTO THE BLOOD VESSEL, HE FOUND RESISTANCE AND COULD NOT PUSH IT FORWARD AT THE KINK IN THE BLOOD VESSEL. WHEN THE SURGEON PULLED IT OUT, THEY FOUND THAT THE TIP WAS DEFORMED AND ENLARGED. THERE WAS A KINK IN THE MIDDLE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A BASILAR ARTERY EMBOLISM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RADIAL ARTERY WITH A DIAMETER OF 2.37. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PATIENT WAS UNDERGOING THROMBECTOMY PROCEDURE. THE CAUSE OF THE RESISTANCE AND DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22416543 ↗
• MalfunctionJul 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE ENCOUNTERED RESISTANCE IN THE MIDDLE OF THE REACT AND THE STENT PUSHWIRE WAS BROKEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING EMERGENCY INTERVENTIONAL THROMBECTOMY FOR TREATMENT OF ISCHEMIC STROKE IN THE MIDDLE CEREBRAL ARTERY. PATIENT CONDITION: MRS BASELINE: 4, MRS PROCEDURE: 4, NIHSS BASELINE: 15, NIHSS POST PROCEDURE: 4, TICI BASELINE: 0, TICI POST PROCEDURE: 3. IV TPA WAS NOT CONTRAINDICATED. THERE WAS 1 PASS WITH THE DEVICE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH AN 11MM DIAMETER. PATIENT HAS A MEDICAL HISTORY OF HYPERTENSION LEVEL 2. STROKE ONSET TO REPERFUSION TIME WAS 4.5 HOURS. IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON WAS PERFORMING AN EMERGENCY THROMBECTOMY ON A PATIENT WITH ACUTE LARGE ARTERY OCCLUSION. THE LESION WAS LOCATED AT THE MIDDLE CEREBRAL ARTERY AT THE END OF THE INTERNAL CAROTID ARTERY. THE SURGEON PLANNED TO USE THE SOLITACT TECHNOLOGY TO REMOVE THE THROMBUS. AFTER THE MICRO-GUIDEWIRE AND MICRO-CATHETER ESTABLISHED THE PATHWAY, THE MICRO-CATHETER PERFORMED PROXIMAL AND DISTAL ANGIOGRAPHY TO DETERMINE THE PROXIMAL AND DISTAL POSITIONS O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394421 ↗
• MalfunctionJun 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE DELIVERY THE SOLITAIRE FR STENT ENCOUNTERED RESISTANCE IN THE MIDDLE OF THE CATHETER. THE STENT DELIVERY WAS DIFFICULT AND THE CAUSE OF RESISTANCE WAS UNCLEAR. THE PATIENT WAS UNDERGOING TREATMENT FOR ISCHEMIC STROKE FROM THE END OF THE INTERNAL CAROTID ARTERY TO THE MIDDLE CEREBRAL ARTERY M1. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE PATIENT'S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 4, WHICH REMAINED THE SAME FOLLOWING THE PROCEDURE. THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE SIGNIFICANTLY IMPROVED, DECREASING FROM A BASELINE SCORE OF 19 TO 3 POST-PROCEDURE. THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE ALSO IMPROVED FROM 0 AT BASELINE TO 3 POST-PROCEDURE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED IN THIS CASE. THE PROCEDURE INVOLVED TWO PASSES WITH THE DEVICE. THE STROKE ONSET TO REPERFUSION TIME WAS 4 HOURS. IT WAS REPORTED THAT THE SURGEON WAS PERFORMING AN EMERGENCY THROMBECTOMY SURGERY. THE SURGEON USED THE SOLITACT TECHNOLOGY, REACT71 CATHETER AND RUIKANGTONG MICROCATHETER, AFTER DETERMINING THE DISTAL AND PROXIMAL POSITIONS, THEY DELIVERED THE STEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150966 ↗
• MalfunctionJun 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2025, HEALTHCARE PROVIDER (HCP) WAS PERFORMING AN EMERGENCY THROMBECTOMY. THE PATIENT WAS AN ACUTE LARGE ARTERY OCCLUSION PATIENT WITH THE LESION AT THE TERMINAL OF THE INTERNAL CAROTID ARTERY. THE SURGEON PLANNED TO USE THE SOLITACT TECHNOLOGY FOR THROMBECTOMY. AFTER THE MICRO-GUIDEWIRE MICRO-CATHETER ESTABLISHED THE ACCESS, THE MICRO-CATHETER PERFORMED PROXIMAL AND DISTAL ANGIOGRAPHY TO CLARIFY THE PROXIMAL AND DISTAL POSITIONS OF THE THROMBECTOMY AND PREPARE TO DELIVER THE THROMBECTOMY STENT. THE STENT SELECTED WAS SFR-6-30. THE SURGEON REPORTED THAT DURING THE PUSH PROCESS, THERE WAS GREAT RESISTANCE NEAR THE Y VALVE. THE SURGEON TRIED TO INCREASE THE FORCE TO PUSH, BUT THE RESISTANCE WAS STILL GREAT. THE SURGEON WITHDREW THE STENT, PERFORMED SECONDARY HYDRATION, AND PUSHED AGAIN, BUT THE SAME RESISTANCE PHENOMENON STILL OCCURRED. FOR THE SAKE OF SURGICAL SAFETY, THE SURGEON DID NOT PUSH THE STENT WITH BRUTE FORCE, WITHDREW THE STENT, AND OBSERVED THE STENT BODY MORPHOLOGY. THE SURGEON BELIEVED THAT THE STENT HAD SOME MORPHOLOGICAL CHANGES. FOR THE SAKE OF SURGICAL SAFETY, DELIVERING THE STENT AGAIN MAY INCREASE THE RISK. THE SURGEON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150651 ↗
• MalfunctionApr 18, 2025Stretched; Difficult to Advance; Physical Resistance/Sticking; Stretched; Difficult to Advance; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A REACT CATHETER STRETCHED AT THE DISTAL SECTION. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A THROMBECTOMY. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE LEFT FEMORAL ARTERY (DIAMETER 5.2 MM). THE ASAHI 0.014 MICRO-GUIDEWIRE WAS PLACED THROUGH THE STRYKER MICRO-CATHETER TO THE STARTING POINT OF THE MIDDLE CEREBRAL ARTERY M1. THE MICRO GUIDEWIRE WAS THEN WITHDRAWN AND REACT-71 WAS INSERTED INTO THE END OF THE INTERNAL CAROTID ARTERY TO EXTRACT THE THROMBUS. DURING THE ASPIRATION PROCESS OF REACT-71, THE TIP OF THE TUBE COULD NOT BE PULLED (REPEATEDLY PULLING, IT HAD ALWAYS BEEN A STATE OF IMMOBILITY). THEN THE TIP FELL DIRECTLY FROM THE ACCESS. AFTER IT FELL, THE SURGEON REMOVED REACT-71 FROM THE BODY AND FOUND THAT THE DISTAL END OF THE INTERMEDIATE CATHETER HAD AN ABNORMAL SHAPE (STRETCHED). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865313 ↗
• MalfunctionApr 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER THE RESISTANCE, THE BLOOD CLOT WAS ASPIRATED AGAIN AND THE OPERATION WAS COMPLETED. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE-SEVERE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE TO THE CATHETER, BUT THE SOLITAIRE PUSHWIRE WAS KINKED IN THE PROXIMAL SEGMENT. THE TIP OF THE SOLITAIRE SHEATH HAD BEEN SECURED IN THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21842190 ↗
• MalfunctionApr 9, 2025Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD INTRACRANIAL POSTERIOR CIRCULATION THROMBOSIS. REACT-71 WAS USED AS A SUPPORT FOR THE INTRACRANIAL THROMBECTOMY STENT SFR4-4-40-10. THE 105-50810153 MICROCATHETER WITH THE GUIDANCE OF THE GUIDEWIRE IN PLACE INTO THE BLOOD SUPPLY ARTERY. THE HAND-PUSH ANGIOGRAPHY WAS USED TO FIND THE RIGHT ANGLE. WHEN THE GUIDE WIRE WAS PLACED IN PLACE UNDER THE ROAD MAP, IT WAS FOUND THAT THE STENT MESH WAS DAMAGED WHEN IT WAS PULLED BACK, WHICH MADE THE STENT UNABLE TO BE PULLED BACK AND CAUSED THE STENT TO BE KINKED. THEN ALL PATHWAYS WERE PULLED OUT OF THE BODY. THERE WAS STENT DAMAGE DURING THE PROCEDURE. THE PROXIMAL END OF THE STENT, THE WIRE WAS BROKEN. RESISTANCE OCCURRED. 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 PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A LARGE ARTERY OCCLUSION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. STROKE ONSET TO REPERFUSION TIME WAS 5 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21807224 ↗
• MalfunctionMar 21, 2025Leak/Splash; Material Deformation; Physical Resistance/Sticking; Leak/Splash; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH A STRYKER PRODUCT. THE CAUSE OF THE LEAKAGE WAS DETERMINED TO HAVE BEEN POSSIBLY DUE TO DAMAGE IN THE MIDDLE OF THE CATHETER. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662734 ↗
• MalfunctionMar 6, 2025Collapse; Physical Resistance/Sticking; Collapse; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DSA AND INTRACRANIAL THROMBECTOMY PROCEDURE, THE REACT-71 CATHETER WAS ROUGH AND COLLAPSED AFTER MULTIPLE ATTEMPTS TO RETRIEVE AND ENTER THE LONG SHEATH. THE PROCEDURE INVOLVED ACCESSING THE INTERNAL CAROTID ARTERY, WHICH HAD A DIAMETER OF 4.2 MILLIMETERS AND MODERATE VESSEL TORTUOSITY. THE CATHETER WAS PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536864 ↗
• MalfunctionFeb 25, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON WAS GOING TO PERFORM A MIDDLE CEREBRAL ARTERY THROMBECTOMY. AFTER THE CATHETER WAS IN PLACE, THE SUCTION WAS NORMAL. THE SUCTION PROCESS HAD GREAT RESISTANCE. WHEN THE CATHETER WAS PULLED OUT OF THE BODY, IT WAS FOUND THAT THE DISTAL END OF THE CATHETER WAS SEVERELY KINKED AND NORMAL SUCTION COULD NOT BE PERFORMED. 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 INTRACRANIAL MIDDLE CEREBRAL ARTERY THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5.5 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458224 ↗
• DeathJan 28, 2025Difficult to Advance; Material Deformation; Physical Resistance/Sticking; Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAS DIED. THE SURGERY WAS COMPLETED AFTER THE MIDDLE CATHETER WAS REMOVED. SINCE THE GUIDEWIRE COULD NOT REACH THE DISTAL OCCLUSION AFTER REPEATED PROBING, NO SUBSEQUENT OPERATION WAS PERFORMED. THE THROMBUS WAS NOT REMOVED. NO ADDITIONAL MEDICAL INTERVENTION WERE DONE FOR THE PATIENT. AFTER THE OPERATION, THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU) ACCORDING TO NORMAL PROCEDURES AND WAS DISCHARGED THREE DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 21253543 ↗
• MalfunctionJan 7, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE REACT-71 CATHETER ENCOUNTERED RESISTANCE IN THE MIDDLE AND WAS DIFFICULT TO PUSH THROUGH THE 8FGUIDE. THE PROCEDURE INVOLVED ACCESSING THE FEMORAL ARTERY, WHICH HAD A DIAMETER OF 10 MILLIMETERS AND MINIMAL VESSEL TORTUOSITY. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION FOR SEVERAL YEARS. THE CATHETER WAS PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS NOT REPLACED BY A MEDTRONIC PRODUCT BUT BY ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093526 ↗
• MalfunctionDec 11, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE TREATMENT OF A THROMBECTOMY IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, DURING THE PROCESS OF THE MICRO-GUIDEWIRE AND MICRO-CATHETER WERE COAXIALLY INTRODUCED INTO THE DISTAL ACCESS AND THE CATHETER TO THE PROXIMAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY THROMBUS, THE DISTAL ACCESS CATHETER WAS NOT SHAPED, THERE WAS AIR RETURN DURING THE 50ML EMPTY NEEDLE ASPIRATION, AND THE NEGATIVE PRESSURE STATE COULD NOT BE MAINTAINED. SO IT WAS TAKEN OUT FOR INSPECTION, AND IT WAS FOUND THAT THE TIP OF THE REACT71 CATHETER WAS FLATTEN AND THE TIP WAS KINKED, SUSPECTED TO BE DAMAGED, SO IT WAS REPLACED. THERE WERE NO SYMPTOMS REPORTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS BEING TREATED FOR A THROMBECTOMY. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 10MM DIAMETER. VESSEL TORTUOSITY WAS MINIMAL. ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE CATHETER DAMAGE WERE: REPLACED IT WITH THE NEW SUCTION CATHETER (B)(6) 2024. SOLVED THE ISSUE. THE CAUSE OF THE CATHETER DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909818 ↗
• DeathJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD UNDERGONE A THROMBECTOMY PROCEDURE IN WHICH A REACT-71 ASPIRATION CATHETER WAS USED TO TREAT ISCHEMIC STROKE. IT WAS REPORTED THAT THE PATIENT NIHSS WAS NOTED TO HAVE DECLINE FROM 23 AT 24-HOURS POST-PROCEDURE ON (B)(6) 2024 TO AN NIHSS SCORE OF 28 AT TIME OF DISCHARGE ON (B)(6) 2024. NO ADDITIONAL INTERVENTION OR ASSOCIATED PATIENT SYMPTOMS WERE REPORTED. THERE WAS ALSO NO REPORT OF ANY ASSOCIATED DEVICE MALFUNCTION OR INTRA-OPERATIVE ISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED PRE-PROCEDURE MTICI 0; BASELINE NIHSS 23. FINAL POST-PROCEDURE MTICI INDETERMINATE ADDITIONAL INFORMATION RECEIVED THAT THE SITE HAS ENTERED A SCORE OF 28. THE CRF HAS NOT YET BEEN SOURCE DATA VERIFIED. THE DECLINE IN THE POST-PROCEDURE DISCHARGE NIHSS SCORE WAS NOT RELATED TO THE REACT-71 ASPIRATION CATHETER PER SITE. THE DECLINE IN THE POST-PROCEDURE DISCHARGE NIHSS SCORE WAS NOT RELATED TO THE INDEX PROCEDURE PER SITE. THE DECLINE IN THE POST-PROCEDURE DISCHARGE NIHSS SCORE WAS PROBABLY RELATED TO THE PATIENT INDEX STROKE/DISEASE UNDER STUDY PER SITE. THE DECLINE IN THE POST-PROCEDURE DISCHARGE NIHSS SCORE WAS PROBABLY RELATED TO AN UNDERLYIN

  Patient problems: Cerebral Edema; Coma; Intracranial Pressure Increased

  MAUDE report 19795455 ↗
• MalfunctionJul 22, 2024Leak/Splash; Difficult to Remove; Stretched; Physical Resistance/Sticking; Leak/Splash; Difficult to Remove; Stretched; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS RESISTANCE WHEN WITHDRAWING REACT71, BUT IT WAS NOT ASSOCIATED WITH ANY OTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791719 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT HAD MILD CEREBRAL EDEMA. HEMATOMA WITHIN ISCHEMIC FIELD WITH MILD SPACE-OCCUPYING EFFECT INVOLVING <(><<)>= 30% OF THE INFARCTED AREA (PH1). THE PATIENT'S FAMILY REQUESTED TO BE DISCHARGED FROM THE HOSPITAL, AND THE SITUATION WILL CONTINUE TO BE FOLLOWED UP AT THE 90 DAY FOLLOW-UP VISIT. NIHSS SCORE AVAILABLE: 35, MRS SCORE: 0. EVENT IS ASSESSED AS POSSIBLE RELATED TO STUDY PROCEDURE. THE EVENT IS RESOLVING. PRE-PROCEDURE MTICI SCORE: 0 FINAL POST-PROCEDURE MTICI SCORE: 3. ADDITIONAL INFORMATION WAS RECEIVED REPORTING SYMPTOMS WERE NOT REPORTED IN THE AE DESCRIPTION, HOWEVER BASELINE NIHSS 35 REMAINED SAME ON THE 24-H POST-PROCEDURE (B)(6) 2024 AND AT DISCHARGE VISIT ON (B)(6) 2024. THERE WAS NO HOSPITALIZATION, NO TREATMENT, AND NO ACTIONS TAKEN TO RESOLVE THE HEMATOMA. ADDITIONAL INFORMATION RECEIVED REPORTED SITE ALSO ADDED AE DESCRIPTION OF HEMORRHAGIC TRANSFORMATION STROKE PH1.

  Patient problems: Hematoma; Hemorrhagic Stroke; Nervous System Injury

  MAUDE report 19733976 ↗
• MalfunctionJun 13, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE REACT CATHETER WAS FOUND KINKED/BROKEN DURING USE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ACUTE GREAT VESSEL OCCLUSION. THE ACCESSED VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT BEFORE THE OPERATION STARTED, THE PRODUCT WAS INSPECTED AND THE REACT71 WAS UNSEALED. NO PROBLEMS WERE FOUND. DURING THE OPERATION, THE REACT71 WAS PUSHED UP TO THE C7 SEGMENT, AND THE THROMBUS WAS CLOSELY CONTACTED FOR SUCTION. IT WAS FOUND THAT THERE WAS NO PRESSURE IN THE SUCTION. AFTER TAKING OUT THE REACT71, IT WAS INSPECTED IN VITRO. IT WAS FOUND THAT THE CATHETER WALL WAS KINKED AND BROKEN, SO A NEW PRODUCT WAS REPLACED TO CONTINUE THE OPERATION. IT WAS REPORTED A CATHETER LEAK OCCURRED IN THE DISTAL SECTION THAT WAS OBSERVED DURING USE. THE CATHETER WAS INSPECTED OR TESTED PRIOR TO USE. 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 RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531296 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A THROMBECTOMY PROCEDURE ON (B)(6) 2024 IN WHICH A REACT-71 ASPIRATION CATHETER WAS USED. POST THROMBECTOMY HEAD COMPUTED TOMOGRAPHY (CT) WAS SUGGESTIVE OF BILATERAL CEREBELLAR HEMISPHERE INFARCTION WITH OBSTRUCTIVE HYDROCEPHALUS. THE PATIENT UNDERWENT CRANIOTOMY DECOMPRESSION AND VENTRICULAR DRILLING FOR EXTERNAL DRAINAGE NEURO SURGERY. THE EVENT PROLONGED THE PATIENT'S HOSPITAL. EVENT WAS NOTED TO BE RESOLVING. SITE ASSESSMENT CONCLUDED THE EVENT HAD A CAUSAL RELATIONSHIP TO THE PATIENT DISEASE UNDER STUDY AND WAS NOT RELATED TO THE DEVICE(S) OR THE PROCEDURE. HOWEVER, THE STUDY SPONSOR ASSESSMENT CONCLUDED THE EVENT WAS POSSIBLY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 19287919 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT EXPERIENCED A CEREBRAL ARTERY EMBOLISM IN THE SAME TERRITORY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THERE WAS NO TREATMENT OR ACTIONS REQUIRED. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERED/RESOLVED. THE ADVERSE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY AND NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE SITE ASSESSED THE ADVERSE EVENT AS NOT RELATED TO THE DEVICES OR STUDY PROCEDURE. THE SPONSOR ASSESSED THE ADVERSE EVENT AS CASUALLY RELATED TO THE STUDY PROCEDURE AND POSSIBLE RELATED TO THE DEVICE UTILIZED.

  Patient problems: Embolism/Embolus

  MAUDE report 19277110 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG CANNOT BE FLIPPED TO 'NO' AS A REGUALTORY REPORT EXISTS IN THIS PE.

  Patient problems: Nervous System Injury

  MAUDE report 19226224 ↗