CEREBASE GS9090SDRecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10886704082293), received between Jul 13, 2020 and Aug 17, 2026 — classified as 2 deaths, 7 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Crack” (52 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 2, 2024Open, Classified

   Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

   Z-1284-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279762 ↗
• MalfunctionAug 11, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209056 ↗
• MalfunctionJun 12, 2026Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE PROXIMAL BODY OF THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31580143) WAS KINKED WHEN THE DEVICE WAS LOCKED WITH THE Y-CONNECTOR. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 02-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE KINK OCCURRED IN PATIENT, PRIOR TO ASPIRATION OR DELIVERY THE STENT RETRIEVER. THE CEREBASE HAD TO BE REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THERE WAS NO PROCEDURE DELAY DUE TO THE ISSUE. THE ADDITIONAL INFORMATION DID NOT INCLUDE THE EVENT DATE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 12-JUN-2026. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25492053 ↗
• MalfunctionMay 19, 2026Crack; Unsealed Device Packaging

  PRIOR TO THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR A 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31749653) FOR INSPECTION. THE PROXIMAL END OF THE CEREBASE CATHETER WAS FOUND CRACKED. THE DEVICE WAS NOT USED FOR THE PROCEDURE IN THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 13-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DEVICE PACKAGING IS AVAILABLE FOR RETURN. THE STERILITY SEAL WAS COMPROMISED. THE REPLACEMENT DEVICE WAS ANOTHER 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222550 ↗
• DeathApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A CEREBASE GS 90, 90 CM, STRAIGHT, DISTAL (GS9090SD/ 31817846) WAS USED FOR A BALLOON-ASSISTED COILING PROCEDURE ON TUESDAY (B)(6) 2026. ¿SHORTLY THEREAFTER, FOLLOW-UP MRI SHOWED MULTIPLE POINT EMBOLIZATION IMMEDIATELY AFTER THE PROCEDURE.¿ ON SATURDAY (B)(6) 2026, THE PATIENT¿S STATUS WAS REPORTED AS ¿GENERALIZED STATUS EPILEPTICUS ON CT SCAN, MULTIPLE HEMORRHAGES ON THE BASAL GANGLIA.¿ THE PATIENT WAS ON ANTICOAGULATION THERAPY, ELIQUIS AND ASPIRIN. ON MONDAY (B)(6) 2026, EDEMA WAS OBSERVED AND THERE WAS CONCERN FOR POSSIBLE FOREIGN BODY REACTION. MEDICATION WAS PAUSED. ON (B)(6) 2026, THE PATIENT¿S STATUS WAS REPORTED AS ¿STILL IN STATUS EPILEPTICUS, ON QUADRUPLE MEDICATION AND TRACHEOTOMIZED.¿ THE EVENT WAS REPORTED AS SUCH, ¿PATIENT WAS SCHEDULED FOR COILING. (B)(6) 2026: BALLOON-ASSISTED COILING STARTED. USED: CEREBASE, ECLIPSE, SL10 EXCELSIOR. SHORTLY THEREAFTER, FOLLOW-UP MRI WITH MULTIPLE POINT EMBOLIZATIONS IMMEDIATELY AFTER THE PROCEDURE. SATURDAY: GENERALIZED STATUS EPILEPTICUS ON CT SCAN, MULTIPLE HEMORRHAGES ON THE BASAL GANGLIA. ELIQUIS AND ASPIRIN. (B)(6) 2026: EDEMA, FOREIGN BODY REACTION? MEDICATION WAS PAUSED.

  Patient problems: Convulsion/Seizure; Foreign Body Reaction; Intracranial Hemorrhage; Swelling/ Edema; Thromboembolism

  MAUDE report 25018700 ↗
• MalfunctionApr 20, 2026Crack

  IT WAS REPORTED THAT PRIOR TO THE START OF AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR A 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31811365) FOR INSPECTION. THE PROXIMAL PART OF THE CEREBASE CATHETER WAS FOUND CRACKED. IT WAS NOT USED FOR THE PROCEDURE, IN THE PATIENT. A PHOTO WAS INCLUDED IN THE COMPLAINT FILE; THE PHOTO WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933821 ↗
• MalfunctionApr 8, 2026Component or Accessory Incompatibility

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING PROCESS OF PROCEDURE PREPARATION, THE PHYSICIAN OPENED THE DEVICE PACKAGING OF A CEREBASE STRAIGHT DISTAL CATHETER (PRODUCT CODE: GS9090SD, LOT NUMBER: 31781389) AND FOUND THE ROTATING MALE LUER CONNECTOR DOES NOT CONNECT WITH THE HEMOSTASIS VALVE FEMALE LUER. THE CEREBASE CATHETER WAS NOT USED IN THE PATIENT. A NEW CATHETER WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION RECEIVED ON 31-MAR-2026 INDICATED THAT THE DEVICE DID NOT APPEAR DAMAGED AT THE CONNECTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820896 ↗
• MalfunctionApr 3, 2026Crack

  IT WAS REPORTED THAT PRIOR TO THE START OF AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR A 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31749653) FOR INSPECTION. THE CEREBASE CATHETER WAS FOUND CRACKED. IT WAS NOT USED FOR THE PROCEDURE, IN THE PATIENT. A PHOTO WAS INCLUDED IN THE COMPLAINT FILE; THE PHOTO WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781442 ↗
• MalfunctionMar 31, 2026Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31467380) WAS DELIVERED IN PLACE AND A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31681991) WAS DELIVERED IN THE CEREBASE. THE MICROCATHETER WAS IMPEDED IN THE DISTAL END OF THE CEREBASE AND COULD NOT PASS THROUGH. THE PHYSICIAN RETRACTED THE MICROCATHETER AND REPLACED IT WITH A SECOND MICROCATHETER. THE SECOND MICROCATHETER ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN REMOVED THE SECOND MICROCATHETER AND THE CEREBASE FROM THE PATIENT AND REPLACED THE CEREBASE WITH ANOTHER CEREBASE TO DELIVER THE SECOND MICROCATHETER AND COMPLETED THE PROCEDURE, WHICH WAS REPORTEDLY PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 31-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS NO ANOMALY OR DAMAGE NOTED ON THE FIRST MICROCATHETER. THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744439 ↗
• MalfunctionMar 23, 2026Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, A CEREBASE 90,60 CM STRAIGHT DISTAL CATHETER WAS DELIVERED IN PLACE. AN INTERMEDIATE CATHETER (COMPETITOR¿S BRAND) WAS ADVANCED THROUGH THE CEREBASE. AFTER PASSING THROUGH THE CEREBASE, THE INTERMEDIATE CATHETER BECAME IMPEDED AT THE DISTAL TIP OF THE CEREBASE AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN REMOVED THE CEREBASE AND INTERMEDIATE CATHETER FROM THE PATIENT. THE DISTAL TIP OF THE CEREBASE WAS OBSERVED TO BE KINKED/BENT. THE PHYSICIAN REPLACED THE DEVICES WITH A NEW CEREBASE AND A NEW INTERMEDIATE CATHETER (COMPETITOR¿S BRAND) AND COMPLETED THE PROCEDURE. THE OUTER PACKAGING AND DEVICE WERE INSPECTED PRIOR TO USE AND WERE REPORTED TO BE IN GOOD CONDITION. THERE WAS NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663977 ↗
• MalfunctionMar 18, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR INSPECTION OF A CEREBASE CATHETER. THE SHAFT OF THE CEREBASE WAS FOUND CRACKED. THE DEVICE WAS NOT USED IN PATIENT. A NEW CEREBASE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-MAR-2026 INDICATED THAT THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625768 ↗
• MalfunctionMar 5, 2026Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE ANGIOPLASTY PROCEDURE ON (B)(6) 2026, THE OUTER DEVICE PACKAGING AND THE DEVICE, A 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31749653), WERE INSPECTED AND FOUND TO BE IN GOOD CONDITION. DURING THE PROCESS OF CREATING ACCESS, THE PHYSICIAN FOUND THAT BLOOD WAS OOZING FROM THE LUER HUB. THE PHYSICIAN INSPECTED THE LUER HUB AND FOUND THAT IT WAS CRACKED. THE DEVICE WAS RETRACTED AND A NEW CEREBASE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. A PHOTO OF THE COMPLAINT DEVICE INCLUDED. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO INCLUDED IN THE COMPLAINT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE MIDDLE CEREBRAL ARTERY (MCA). IT WAS NOT AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) CASE. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS WITH ACUTE BENDS. THERE WAS NO DIFFICULTY IN REMOVING THE DEVICE FROM THE PACKAGING. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT. THERE WAS A ¿10-15-MINUTE¿ DELAY, HOWEVER, WHETHER THE DELAY WAS CLINICALLY SIGNIFICANT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520369 ↗
• MalfunctionFeb 25, 2026Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, AFTER THE CEREBASE GUIDE SHEATH (PRODUCT CODE: GS9090SD, LOT NUMBER: 31711074) WAS POSITIONED, THE INTERMEDIATE CATHETER (NON J&J) BECAME IMPEDED AT THE DISTAL END OF THE CEREBASE AND WAS UNABLE TO ADVANCE THROUGH IT. THE PHYSICIAN REMOVED BOTH THE CEREBASE AND THE INTERMEDIATE CATHETER FROM THE PATIENT. A NEW CEREBASE WAS THEN INTRODUCED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL INTERMEDIATE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444154 ↗
• MalfunctionFeb 23, 2026Crack; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO THE START OF A PROCEDURE, WHEN THE PACKAGING FOR THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31766742) WAS OPENED, THE DEVICE WAS FOUND TO BE FOLDED AND KINKED, RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO. ON 16-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS ON (B)(6) 2026. THE LOT NUMBER OF THE CEREBASE WAS 31766742. THE PROCEDURE WAS TO TREAT AN ISCHEMIC STROKE. THE INFORMATION INDICATED THAT NOTHING UNUSUAL WAS NOTED ABOUT THE PACKAGING, ¿THE PACKAGING WAS GOOD BECAUSE THERE WERE OTHER CEREBASE AND THEY WERE IN GOOD CONDITION.¿ THE DEVICE PACKAGING FOR THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24418109 ↗
• MalfunctionFeb 17, 2026Device-Device Incompatibility

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE VALVE COULD NOT BE FASTENED ONTO THE HUB OF THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31756110). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT; THE PROCEDURE WAS DELAYED BY 5 MINUTES. A SHORT MP.4 VIDEO DOCUMENTING THE REPORTED ISSUE WAS INCLUDED IN THE COMPLAINT. THE MP.4 WILL B REVIEWED BY THE PRODUCT ANALYSIS TEAM. ON 11-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TO TREAT A STROKE WITH THE OCCLUSION IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PROCEDURE WAS NOT AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE). THE PROCEDURE WAS COMPLETED WITH A NEURONMAX AS THE REPLACEMENT DEVICE. THE PHYSICIAN DID NOT CONSIDER THE REPORTED 5-MINUTE DELAY IN THE PROCEDURE TO BE CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370487 ↗
• MalfunctionFeb 4, 2026Crack; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN INSPECTED THE DEVICE PACKAGING, AND IT WAS NOTED TO BE IN GOOD CONDITION. THE PHYSICIAN THEN OPENED THE DEVICE PACKAGING FOR INSPECTION, AND THE PROXIMAL END OF THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31711074) WAS FOUND TO BE KINKED / BENT. THE DEVICE WAS NOT USED FOR THE PROCEDURE / IN THE PATIENT. THE PHYSICIAN REPLACED THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 02-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WAS A BREAK IN THE MATERIAL INTEGRITY AT THE SITE OF THE REPORTED DEFECT. THERE WAS NO DIFFICULTY IN REMOVING THE DEVICE FROM THE PACKAGING; IT WAS INDICATED THAT THE ORIGINAL PACKAGING IS AVAILABLE FOR RETURN. THERE WAS NO PROCEDURE DELAY DUE TO THE REPORTED ISSUE. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 02-FEB-2026, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259481 ↗
• MalfunctionJan 12, 2026Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31467375) WAS DELIVERED TO THE TARGET POSITION. THE INTERMEDIATE CATHETER (UNSPECIFIED BRAND) WAS IMPEDED IN THE DISTAL END OF THE CEREBASE AND COULD NOT PASS THROUGH. THE PHYSICIAN REMOVED THE INTERMEDIATE CATHETER AND THE CEREBASE FROM THE PATIENT; THE PHYSICIAN REPLACED THE CEREBASE WITH ANOTHER CEREBASE CATHETER AND COMPLETED THE PROCEDURE WITH THE ORIGINAL INTERMEDIATE CATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24047658 ↗
• MalfunctionDec 3, 2025Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE DOCTOR OPENED THE PACKAGE OF A AND TOOK OUT THE CEREBASE DA GUIDE SHEATH (PRODUCT CODE: GS9090SD, LOT NUMBER: 31411445) FOR INSPECTION AND OBSERVED THE PROXIMAL END OF THE CEREBASE WAS KINKED/BENT. THE CEREBASE WAS NOT USED IN THE PATIENT. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-NOV-2025 INDICATED THAT THERE WAS NO DIFFICULTY IN REMOVING DEVICE FROM PACKAGING. THERE WAS A DEVICE FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706546 ↗
• MalfunctionDec 2, 2025Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT A CEREBASE CATHETER 90, 90 CM, STRAIGHT, DISTAL (PRODUCT CODE: GS9090SD, LOT NUMBER: 31681997) WAS DISCOVERED TO BE CRACKED WHEN THE PACKAGING WAS OPENED FOR INSPECTION BEFORE THE PROCEDURE, AND IT WAS NOT USED IN THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE SURGERY, AND THERE WAS NO REPORTED PATIENT INJURY OR CONSEQUENCE. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-NOV-2025 INDICATED THAT THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693738 ↗
• MalfunctionNov 18, 2025Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR INSPECTION. THE SECTION NEAR THE LUER HUB OF THE PROXIMAL PART OF THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31660065) WAS FOUND CRACKED. THE DEVICE WAS NOT USED FOR THE PROCEDURE IN THE PATIENT. THERE WAS NO NEGATIVE PATIENT IMPACT. A SHORT VIDEO WAS INCLUDED IN THE COMPLAINT FOR REVIEW. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WAS NO DAMAGE NOTED ON THE DEVICE BOX AND PACKAGING. THE REPLACEMENT WAS ANOTHER 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD). THE WAS NO DELAY IN THE PROCEDURE DUE TO THE ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589429 ↗
• MalfunctionNov 12, 2025Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR INSPECTION. THE PROXIMAL PART OF THE CEREBASE CATHETER WAS FOUND CRACKED. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534051 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE PACKAGE OF A CEREBASE GUIDE CATHETER (GS9090SD, 31395243) WAS INSPECTED AND IN GOOD CONDITION. WHEN CONNECTING THE CEREBASE TO THE Y CONNECTOR, IT WAS OBSERVED THAT SALINE ESCAPED FROM THE CONNECTION OF CEREBASE LUER HUB AND THE Y CONNECTOR. THE DOCTOR STILL USED THE CEREBASE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-JUL-2025 INDICATED THAT THE DEVICE DID NOT APPEAR KINKED, COMPRESSED, CRACKED OR DAMAGED IN ANY OTHER WAY. THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE. THE DEVICE DEFICIENCY DID NOT RESULT IN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441501 ↗
• MalfunctionJul 1, 2025Crack; Difficult to Advance; Crack; Difficult to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTERNAL CAROTID ARTERY EMBOLECTOMY OF THE C6 SEGMENT, A CEREBASE 90, 90 CM, STRAIGHT, DISTAL CATHETER WAS IMPEDED IN C1 SEGMENT OF THE INTERNAL CAROTID AND COULD NOT REACH THE TARGET POSITION. THE POLYMER MATERIAL OF THE CEREBASE WAS FOUND CRACKED. THE DOCTOR REMOVED THE CEREBASE FROM THE PATIENT AND SWITCHED TO NEW DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTED THAT PRIOR TO THE PROCEDURE, THE DEVICE PACKAGING AND DEVICE WERE IN GOOD CONDITION. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUN-2025 INDICATED THAT THE VESSEL WAS TORTUOUS. THE CATHETER WAS NOTED TO BE CRACKED WHEN IMMEDIATELY WITHDRAWN. THE CAUSE OF THE EVENT OR FACTORS CONTRIBUTING TO THE EVENT KNOWN ARE NOT KNOWN. THE CEREBASE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WAS NO ADDITIONAL INTERVENTION NEEDED TO REMOVE THE DEVICE FROM THE PATIENT. AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THE DEVICE WAS USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT. THERE WAS NO ALLEGATION OF PATIENT IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376119 ↗
• MalfunctionJun 30, 2025Crack; Crack

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL, PRIOR TO USE, THE PACKAGING OF A CEREBASE CATHETER (GS9090SD, 31498850) WAS IN GOOD CONDITION. THE PHYSICIAN OPENED DEVICE PACKAGING FOR INSPECTION, THE PROXIMAL PART OF THE CATHETER WAS FOUND CRACKED. THE DEVICE WAS NOT USED IN PATIENT. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 20-JUN-2025 INDICATING THAT THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358980 ↗
• MalfunctionJun 18, 2025Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE PROCEDURE, THE OUTER PACKAGING AND THE CEREBASE 90, 90 CM, STRAIGHT, DISTAL (GS9090SD/31450746) WERE INSPECTED AND FOUND IN GOOD CONDITION. WHEN THE LUER HUB OF THE CEREBASE CATHETER WAS CONNECTED TO THE Y-CONNECTOR, IT WAS OBSERVED THAT THE LUER HUB OF THE CEREBASE WAS BROKEN. THE CATHETER WAS NOT USED IN THE PATIENT. A NEW CATHETER WAS SWITCHED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES NOR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282881 ↗