REACT™ REACT-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00847536041967), received between Jun 4, 2021 and Oct 27, 2025 — classified as 3 deaths, 13 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (18 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 45 reports, in the reporter's own words as published by the FDA.

• DeathOct 27, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED REPORTED THE SITE AND STUDY INVESTIGATOR CONFIRMED THERE AS NO SUBARACHNOID HEMORRHAGE PRESENT ON IMAGING. THE PATIENT DIED AT THE IN-PATIENT REHAB FACILITY. AUTOPSY RECORDS WERE NOT MAID AVAILABLE BUT THE SITE CONFIRMED THE EVENT WAS RELATED TO THE PATIENT'S PRE-EXISTING MEDICAL HISTORY OF HEART FAILURE AND WAS NOT DUE TO SUBARACHNOID HEMORRHAGE. THE PATIENT DEATH WAS UNRELATED TO THE STUDY PROCEDURE OR MEDTRONIC DEVICES USED IN THE PROCEDURE. AS THERE WAS NO DEVICE MALFUNCTION, CONFIRMED THERE WAS NO SUBARACHNOID HEMORRHAGE EVENT, AND THE PATIENT'S DEATH WAS UNRELATED TO ANY MEDTRONIC DEVICE OR THE PROCEDURE, THE EVENT NO LONGER MEETS THE DEFINITION OF A COMPLAINT PER 027-WI185. THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENT REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

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

  MAUDE report 23398943 ↗
• MalfunctionAug 4, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT WAS ADMITTED TO THE OPERATING TABLE FOR AN ACUTE CEREBRAL INFARCTION. ANGIOGRAPHY REVEALED SEVERE TORTUOSITY OF THE RIGHT INTERNAL CAROTID ARTERY AND THROMBOSIS OF THE IPSILATERAL M1 MIDDLE CEREBRAL ARTERY. A 90 LONG SHEATH, FITTED WITH A REACT-68 CATHETER, MICROCATHETER, AND MICRO GUIDEWIRE, WERE PLACED AND ASPIRATION WAS PERFORMED. DURING ASPIRATION, EXCESSIVE RESISTANCE WAS FELT. AFTER UNSUCCESSFUL ATTEMPTS, IT WAS WITHDRAWN, BUT THE TIP WAS FOUND TO BE DEFORMED. A NEW CATHETER WAS SUBSEQUENTLY REPLACED. A COMBINATION OF PUMPING AND PULLING WAS USED UNTIL THE VESSEL WAS SUCCESSFULLY RECANALIZED, CONCLUDING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR THROMBECTOMY OF THE RIGHT INTERNAL CAROTID ARTERY FOR ACUTE CEREBRAL INFARCTION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH AN 8MM DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701205 ↗
• InjuryJul 23, 2025Adverse 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 FOR TREATMENT OF ISCHEMIC STROKE. A REACT-68 ASPIRATION CATHETER AND SOLITAIRE PLATINUM (SFR3) STENT RETRIEVER WERE USED IN THE PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION. THE PATIENT'S BASELINE TICI WAS 0; NIHSS WAS 13. TICI 2B WAS ACHIEVED IN THE PROCEDURE. IT WAS REPORTED THAT IN POST-OPERATIVE IMAGING ON (B)(6) 2024, HEMORRHAGIC TRANSFORMATION OF THE INFARCT AREA WAS OBSERVED THAT HAD NOT BE NOTED IN INDEX PROCEDURE IMAGING. THERE WAS NO ADDITIONAL TREATMENT OR INTERVENTION FOR THE HEMORRHAGE EVENT AND IT WAS NOTED TO BE RESOLVING AND THE PATIENT IS RECOVERING. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY, NOR DID IT PROLONG THE PATIENT'S HOSPITALIZATION. SITE ASSESSMENT CONCLUDED THE EVENT WAS NOT RELATED TO THE PROCEDURE OR MEDTRONIC DEVICES. THE MEDTRONIC STUDY SPONSOR ASSESSMENT CONCLUDED THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE. 2024-AUG-26 (B)(4) (FOR, HCP, SDY): ADDITIONAL INFORMATION WAS RECEIVED THAT THE OUTCOME WAS RECOVERED/RESOLVED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED REPORTED THE MRS SCORE WAS

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22583138 ↗
• MalfunctionJun 21, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A REACT CATHETER WAS KINKED IN THE PROXIMAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY. IT WAS REPORTED THAT DURING THE LEFT MIDDLE CEREBRAL ARTERY THROMBECTOMY, WHEN THE DISTAL ACCESS CATHETER WAS UNSEALED, IT WAS FOUND THAT THE TAIL END OF THE CATHETER WAS BROKEN, AND THE CATHETER WAS REPLACED AND THE OPERATION WAS COMPLETED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DAMAGE WAS NOTICED WHEN OPENING THE PACKAGE AND NO FURTHER PREPARATION WAS TAKEN. IT WAS CLARIFIED THAT THE CATHETER WAS JUST KINKED. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303492 ↗
• MalfunctionJun 20, 2025Break; Collapse; Packaging Problem; Break; Collapse; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE CEREBRAL ARTERY THROMBUS WAS REMOVED. THE REACT-68 CATHETER TIP WAS FOUND TO HAVE A BREAK AND WAS NOT USED. IT WAS REPLACED WITH A NEW REACT-68 TO COMPLETE THE OPERATION. THE DISTAL END WAS ALSO REPORTED TO HAVE BEEN CRUSHED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR MIDDLE CEREBRAL ARTERY EMBOLECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 6MM DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296860 ↗
• InjuryJun 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED CAUSALITY ASSESSMENT PROVIDED AS: POSSIBLE RELATED TO PROCEDURE, NOT RELATED TO DEVICES, NOT RELATED TO DISEASE UNDER STUDY, NOT RELATED TO UNDERLYING CONDITION OR DISEASE, THE RATIONALE FOR THE RELATIONSHIP TO SYSTEM OR PROCEDURE: IT SEEMS THE THROMBUS WAS DISLODGED AND MIGRATED DURING REMOVAL.

  Patient problems: Embolism/Embolus

  MAUDE report 22208746 ↗
• MalfunctionJun 3, 2025Collapse; Leak/Splash; Collapse; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE PROXIMAL SECTION OF THE CATHETER WAS CRUSHED. THE PATIENT WAS UNDERGOING RIGHT MIDDLE CEREBRAL ARTERY THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHEN THE SURGEON WAS PERFORMING THE MIDDLE CEREBRAL ARTERY THROMBECTOMY, BLOOD CAME OUT OF THE CATHETER TAIL END. 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 WAS RECEIVED THAT THE CAUSE OF THE CATHETER DAMAGE WAS NOT DETERMINED. IT WAS CLARIFIED THAT THE CATHETER WAS LEAKING. AFTER TAKING IT OUT OF THE PACKAGE AND OPERATING IT NORMALLY, BLOOD WAS FOUND AT THE TAIL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131786 ↗
• MalfunctionMay 12, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS AND DAMAGER WERE CAUSED BY THE CATHETER TIP BEING DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002625 ↗
• MalfunctionMay 8, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REBAR ENCOUNTERED RESISTANCE AT THE KINKED LOCATION, AND THE REACT-68 HAD NO RESISTANCE IN ANOTHER GUIDE CATHETER. IT WAS CLARIFIED THAT A REACT-71 CATHETER WAS NOT USED DURING THE PROCEDURE. THIS WAS A DESCRIPTION ERROR AND ONLY REACT-68 WAS USED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989259 ↗
• MalfunctionApr 28, 2025Difficult to Advance; Material Deformation; Physical Resistance/Sticking; Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A REACT CATHETER KINKED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A THROMBECTOMY FOR CEREBRAL INFARCTION. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY (DIAMETER 9 MM). THE PATIENT WAS ON THE OPERATING TABLE DUE TO ACUTE CEREBRAL INFARCTION. ANGIOGRAPHY REVEALED SEVERE TORTUOSITY OF THE LEFT INTERNAL CAROTID ARTERY AND THROMBOSIS OF THE IPSILATERAL MIDDLE CEREBRAL ARTERY M1. AFTER THE MICRO-GUIDEWIRE AND MICROCATHETER ARRIVED AT THE LOCATION, THEY WERE PREPARED TO ASPIRATE IN PLACE. WHEN THE REACT CATHETER WAS PUSHED UPPER, REPEATED ATTEMPTS WERE MADE, BUT THE CATHETER WAS DIFFICULT TO REACH THE LESION. AFTER THE CATHETER WAS REMOVED, IT WAS FOUND KINKED. TO ENSURE THE SAFETY OF THE OPERATION, IT WAS REPLACED WITH ANOTHER ONE, AND THE THROMBUS WAS SUCCESSFULLY REMOVED, AND THE SURGERY WAS COMPLETED. 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 21918367 ↗
• MalfunctionApr 2, 2025Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT IT WAS PLANNED TO USE THE REACT-68 ASPIRATION CATHETER DURING A MECHANICAL THROMBECTOMY PROCEDURE.  HOWEVER, AFTER OPENING THE REACT-68 PACKAGE, THE CATHETER WAS FOUND TO BE BROKEN SO IT COULD NOT BE USED. IT WAS REPLACED FOR THE PROCEDURE.  IT WAS NOTED THAT THE REACT CATHETER AND ALL ACCESSORY DEVICES WERE PREPARED AND CATHETER FLUSHED ADMINISTERED PER THE INSTRUCTIONS FOR USE (IFU).  AS THE ISSUE WAS OBSERVED PRIOR TO USE, IT IS CONSIDERED THAT THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753408 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE ADVERSE EVENT RESULTED IN A PROLONGATION OF EXISTING HOSPITALIZATION. THERE WAS A PERMANET IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION INCLUDING CHRONIC DISEASES. THE OUTCOME IS NOT RESOLVED. NO TREATMENT OR ACTIONS TAKEN.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion; Stenosis

  MAUDE report 20788093 ↗
• InjuryOct 15, 2024Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE REACT 68 CATHETER SEPARATED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA), WHICH WAS 3-4MM IN DIAMETER. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE REACT 68 CATHETER WAS USED IN COMBINATION WITH A SOLITAIRE TO PERFORM ASPIRATION AND THROMBECTOMY. THE SOLUMBRA PROCEDURE WAS PERFORMED THREE TIMES. HOWEVER, DURING THE FOURTH THROMBECTOMY ATTEMPT, IT WAS DISCOVERED THAT THE COIL AT THE DISTAL END OF THE REACT 68 HAD PROTRUDED FROM THE CATHETER, CONFIRMING A SEPARATION BETWEEN THE COIL AND THE CATHETER. THE DOCTOR IMMEDIATELY REPLACED THE CATHETER WITH A REACT 71 TO CONTINUE THE PROCEDURE. THE PATIENT¿S EMBOLISM WAS LOCATED BETWEEN C2 AND C6 SEGMENTS, AND A TOTAL OF 9 THROMBECTOMIES WERE PERFORMED. THE ASPIRATION CATHETER WAS POSITIONED IN THE ICA AROUND THE C5-C6 REGION. AFTER PERFORMING DSA IMAGING, IT WAS OBSERVED THAT BOTH THE ANTERIOR CEREBRAL ARTERY (ACA) AND MIDDLE CEREBRAL ARTERY (MCA) WERE OPEN, BUT AFTER THE ASPIRATION CATHETER WAS REMOVED, THE OCCLUSION REAPPEARED. SINCE 9 THROMBECTOMIES HAD ALREADY BEEN PERFORMED, THE DOCTOR WAS

  Patient problems: Cerebral Edema; Hematoma; Obstruction/Occlusion

  MAUDE report 20453056 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECOVERED/RESOLVED ON 2024-04-11. IT WAS NOTED THAT EXPANSION INFARCTION WAS NOT CLINICALLY SIGNIFICANT. THERE WAS NO TREATMENT FOR THE EVENT.

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 19912157 ↗
• MalfunctionJul 12, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER FINDING THAT THE TIP OF THE TUBE HAD FALLEN OFF, A NEW REACT 68 TUBE WAS REPLACED FOR SURGERY. THE CAUSE OF THE CATHETER FRACTURE WAS NOT DETERMINED. ALL OF THE CATHETER FRAGMENTS WERE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729445 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A REACT CATHETER PATIENT EXPERIENCED A SUBARACHNOID HEMORRHAGE (SAH) THAT WAS OBSERVED ON 24H POST-PROCEDURE CT/MRI PERFORMED ON (B)(6) 2024, EXPANSION OF INDEX INFARCT WAS ALSO REPORTED. IT WAS UNKNOWN IF THERE WAS/WERE THERE ANY IMPACT(S) TO THE PATIENT. IT WAS UNKNOWN IF ANY ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT.

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 19725341 ↗
• MalfunctionJul 3, 2024Break; Stretched; Material Deformation; Break; Stretched; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE GUIDEWIRE WAS KINKED AND CATHETER RUPTURED. THE PATIENT ALSO HAD INTRACRANIAL HEMORRHAGE DURING THE OPERATION, AND IT WAS UNCLEAR WHETHER IT WAS CAUSED BY CATHETER RUPTURE. THE PATIENT WAS UNDERGOING THROMBECTOMY FOR ACUTE ISCHEMIC STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8MM. IT WAS REPORTED THAT THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO RIGHT-SIDE LIMB DYSFUNCTION AND SLURRED SPEECH. THE EMERGENCY DIAGNOSIS WAS LEFT MIDDLE CEREBRAL ARTERY OCCLUSION, AND EMERGENCY THROMBECTOMY WAS PLANNED TO PERFORM. AFTER ANGIOGRAPHY, IT WAS CONFIRMED THAT THE PATIENT'S LEFT MIDDLE CEREBRAL ARTERY M1 DISTAL OCCLUSION WAS CONFIRMED. THE SURGEON THEN FORMULATED A TREATMENT STRATEGY AND STARTED THROMBECTOMY. 8FGUDING WAS LINED WITH 5F125 MULTIFUNCTIONAL CATHETER. UNDER THE GUIDANCE OF LOACH GUIDE WIRE, 8FGUDING REACHED C1 SEGMENT OF INTERNAL CAROTID ARTERY. THE SURGEON THEN USED REACT-68 FOR PROXIMAL SUPPORT AND A 0.14 AVIGO GUIDEWIRE OUTER-LINED WITH A REBAR18 MICROCATHETER TO PASS THROUGH THE OCCLUDED SEGMENT AND FIND THE TRUE LUMEN. THE GUIDEWIRE WAS INITIALLY PUS

  Patient problems: Coma; Intracranial Hemorrhage

  MAUDE report 19666816 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A REACT-68 CATHETER AND SOLITAIRE SFR4 STENT HAD COMPLICATIONS. BRAIN DWI PERFORMED THE DAY AFTER THE PROCEDURE SHOWED NEW CEREBRAL INFARCTIONS IN BOTH CEREBELLUMS. CEREBRAL INFARCTION MAY PROGRESS UNRELATED TO THE PROCEDURE, OR A SMALL AMOUNT OF CEREBRAL INFARCTION MAY OCCUR DUE TO THE PROCEDURE. NIHSS SCORE: 4, MRS SCORE: 0. NO ACTIONS WERE TAKEN. THE EVENT RESOLVED ON 2024-MAY-11. THE EVENT WAS POSSIBLY RELATED TO THE STUDY PROCEDURE DEVICES UTILIZED, AND DISEASE UNDER STUDY. PRE-PROCEDURE MTICI SCORE: 0. FINAL POST-PROCEDURE MTICI SCORE: 3

  Patient problems: Ischemia

  MAUDE report 19660399 ↗
• MalfunctionJun 27, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S BASELINE (TICI, NIHSS ETC.) WAS UNKNOWN. THE PATIENT¿S POST-THROMBECTOMY CONDITION (TICI, NIHSS, ETC.) THE PATIENT RETURNED TO NORMAL. VESSEL TORTUOSITY WAS NORMAL. THE PATIENT WAS RECOVERING WELL FROM THE PROCEDURE, ALL LIMBS CAN MOVE. NO PATIENT SYMPTOMS WERE REPORTED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623561 ↗
• MalfunctionMay 1, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT AFTER ESTABLISHING THE ACCESS AND CONNECTING THE DRIP, THE SURGEON FOUND FLUID LEAKAGE FROM THE HUB PROXIMAL TO THE REACT68, WHICH AFFECTED THE NORMAL OPERATION, SO HE REPLACED IT WITH ANOTHER 68 FOR SURGERY. THERE WAS CATHETER LEAK/STRAIN RELIEF. THE CATHETER WAS NOT INSPECTED PRIOR TO USE. THE LEAK WAS OBSERVED DURING PREPARATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226068 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTORNIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A REACT-68 CATHETER AND SOLITAIRE SFR4 STENT HAD INCREASED EXTENT OF MIDDLE CEREBRAL ARTERY INFARCTION WAS SEEN IN THE FOLLOW UP IMAGE. THIS IS NOT CLINICALLY SIGNIFICANT. THERE WAS NO TREATMENT FOR THIS EVENT. NIHSS SCORE: 9, MRS SCORE: 5. THE EVENT IS RESOLVING. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE PROCEDURE. LOCATION OF PROXIMAL FACE OF CLOT 1: PRE-PROCEDURE MTICI SCORE: 2A. FINAL POST-PROCEDURE MTICI SCORE: 0.

  Patient problems: Ischemia Stroke

  MAUDE report 19006847 ↗
• DeathMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE SITE VERIFIED AND UPDATED THE FINAL MTICI SCORE TO 2A; THEREFORE, THERE WAS NO FAILED RECANALIZATION TO BE REPORTED. THE SITE VERIFIED FOLLOW UP IMAGING SHOWED EXPANSION OF THE INDEX INFARCTION.

  Patient problems: Insufficient Information; Intracranial Hemorrhage; Ischemia; Ischemia Stroke; Obstruction/Occlusion

  MAUDE report 18907328 ↗
• MalfunctionMar 6, 2024Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE REACT CATHETER WAS FOUND KINKED. THE PATIENT WAS UNDERGOING INTERVENTIONAL THROMBECTOMY. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT BEFORE THE OPERATION, WHEN THE PROTECTIVE PLATE WAS PULLED OUT, IT WAS FOUND THAT THE PROXIMAL END OF THE REACT CATHETER WAS KINKED AND BROKEN. IT WAS REPORTED THE CATHETER WAS KINKED IN THE PROXIMAL 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 RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE CATHETER KINK WAS NOT DETERMINED. IT WAS CLARIFIED THAT THE CATHETER WAS JUST KINKED. IT WAS NOTED THAT THE CATHETER DAMAGE WAS SEEN PRIOR TO PREPARATION. THE DAMAGE WAS NOT SEEN IMMEDIATELY AFTER OPENING THE PACKAGE. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847479 ↗
• InjuryFeb 27, 2024Stretched; Device Dislodged or Dislocated; Material Deformation; Physical Resistance/Sticking; Stretched; Device Dislodged or Dislocated; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S COMA WAS DUE TO A LONG INFARCTION THAT AFFECTED IMPORTANT FUNCTIONAL AREAS AND WAS NOT DIRECTLY RELATED TO THE DEVICE.

  Patient problems: Coma; Foreign Body In Patient

  MAUDE report 18789898 ↗
• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S SYMPTOMS IN PRESENTING FOR STROKE TREATMENT WERE GRADUALLY WORSENING LEVEL OF CONSCIOUSNESS AND COMA, WITH NO OTHER OBVIOUS STROKE SYMPTOMS. THE INDEX CLOT BEING TREATED WAS LOCATED IN THE BASILAR ARTERY. THE PATIENT'S PRE-PROCEDURE NIHSS WAS 36 AND TICI WAS 1. TICI 3 WAS ACHIEVED IN THE PROCEDURE AND THE PATIENT'S POST-PROCEDURE NIHSS WAS 28. THE PATIENT WAS RECOVERING WELL. DUAL ANTIPLATELET THERAPY WAS ADMINISTERED TO PREVENT THROMBOSIS OF THE CATHETER MARKER.

  Patient problems: Foreign Body In Patient

  MAUDE report 18789082 ↗