CEREBASE GS9095SDRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886704082323), received between Sep 23, 2020 and Apr 27, 2026 — classified as 1 death, 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Crack” (16 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, 2024Class IOpen, 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT A CEREBASE CATHETER (PRODUCT CODE: GS9095SD, LOT NUMBER: 31736508), ¿CAME OUT OF THE PACKAGING BENT AS SOON AS IT WAS UNPACKED". THE PRODUCT WAS ONLY REMOVED, NOT INSERTED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-APR-2026 INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT. THE PRODUCT WAS ALREADY BROKEN INSIDE THE PACKAGING AND WAS ALMOST IN TWO PIECES. THERE WAS SO DAMAGE TO THE PACKAGING. THERE NO DIFFICULTY IN REMOVING DEVICE FROM PACKAGING, THE DEVICE COULD BE REMOVED EASILY, AND THE DEFECT WAS IMMEDIATELY VISIBLE. THE CUSTOMER DISPOSED OF THE PACKAGING. THE CEREBASE WAS DAMAGED WHEN TAKEN OUT OF THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999184 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT A CEREBASE GS 90, 95 CM, STRAIGHT DISTAL CATHETER (PRODUCT CODE: GS9095SD, LOT NUMBER: 31756112) WAS BEING GIVEN CONTRAST, HOWEVER, IT DIDN'T REACH THE DISTAL END OF THE CEREBASE. ON IMAGING, THE USER REALIZED THAT IT WAS COMING OUT OF THE PROXIMAL END (AS WELL AS BLOOD) SLIGHTLY ABOVE THE HUB. THERE WAS A KINK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726821 ↗
• MalfunctionFeb 25, 2026Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION THE PROCEDURE, THE PHYSICIAN OPENED THE PACKAGE OF A CEREBASE 90, 95 CM, STRAIGHT, DISTAL CATHETER (PRODUCT CODE: GS9095SD, LOT NUMBER: 31375560) AND TOOK IT OUT FOR INSPECTION. THE TIP OF THE CEREBASE CATHETER WAS KINKED/BENT. THE CEREBASE CATHETER WAS NOT USED IN THE PATIENT. A NEW DEVICE WAS SWITCHED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE RETURNED DEVICE, THE LUER HUB IS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446316 ↗
• MalfunctionFeb 5, 2026Material Separation

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, THE CEREBASE 95 CM GUIDE CATHETER DISTAL ACCESS (PRODUCT CODE: GS9095SD, LOT NUMBER: 31736507) WAS USED. THE HUB SEPARATED FROM THE CATHETER AND THE BRAID WIRE BECAME EXPOSED AT THE HUB END. IT IS POSSIBLE THE CEREBASE WAS DAMAGED WHEN REMOVED FROM THE PACKAGING BUT COULD NOT CONFIRM. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-JAN-2026 INDICATED THAT THE DEVICE MIGHT HAVE BEEN ¿HEAVY-HANDED¿ BY THE USER. THERE WAS NO DAMAGE NOTED TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269590 ↗
• MalfunctionDec 1, 2025Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR THE 95CM CEREBASE STRAIGHT DA GUIDE SHEATH (GS9095SD / 31450747) FOR INSPECTION AND THE CEREBASE WAS FOUND TO BE KINKED / BENT. THE DEVICE WAS NOT USED IN THE PATIENT. A NEW CEREBASE WAS USED TO CONTINUE WITH THE PROCEDURE. IT WAS THEN REPORTED THAT WHEN DELIVERING THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212 / 9550017), THE STENT WAS IMPEDED IN THE Y-CONNECTOR AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN RETRACTED THE STENT AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 05-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WAS NO DAMAGE NOTED ON THE CEREBASE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE CEREBASE FROM THE PACKAGING. THE INFORMATION ALSO INDICATED THAT THE DEVICE PACKAGING IS AVAILABLE FOR RETURN. THERE WAS NO BREAK IN THE DEVICE INTEGRITY. THERE WAS NO DAMAGE NOTED ON THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212). NOTHING WAS NOTED TO BE OBSTRUCTING THE INTRODUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689325 ↗
• MalfunctionJun 10, 2025Crack; Crack

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PREPPING OF A CEREBASE STRAIGHT DISTAL CATHETER (GS9095SD, 31403082) CRACKED. THE OUTER PACKAGING WAS INSPECTED AND FOUND IT WAS IN GOOD CONDITION. THE DOCTOR OPENED THE PACKAGE AND TOOK OUT THE CEREBASE AND RINSED IT, BUT IT WAS OBSERVED THAT THE SHAFT OF THE CEREBASE. THE DEVICE WAS NOT USED IN PATIENT. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-MAY-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. THERE WAS NO EXCESSIVE FORCE USED WHILE HANDLING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175613 ↗
• MalfunctionMay 2, 2025Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF A MECHANICAL THROMBECTOMY PROCEDURE, THE 95CM CEREBASE STRAIGHT DA GUIDE SHEATH (GS9095SD / 31467382) WAS FOUND BROKEN IN THE PACKAGING WITH NO SIGN OF DAMAGE TO THE PACKAGING. A NEW CEREBASE CATHETER WAS USED AS A REPLACEMENT. THERE WAS NO IMPACT ON THE PATIENT. NO DELAY TO THE PROCEDURE. ON 29-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CEREBASE CATHETER WAS SEPARATED INTO TWO OR MORE FRAGMENTS. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 29-APR-2025, THE REPORTED EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954648 ↗
• MalfunctionFeb 7, 2025Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE HUB OF THE CEREBASE DEVICE (CATALOG / LOT# UNKNOWN) WAS CRACKED. WHEN SALINE WAS BEING INJECTED, IT WAS NOT FLOWING THROUGH THE CATHETER; IT WAS COMING OUT AT THE CRACKED HUB. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339756 ↗
• MalfunctionFeb 7, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, DURING THE PROCESS OF CREATING AN ACCESS, A GAP WAS FOUND IN THE CONNECTION OF THE LUER HUB OF THE 95CM CEREBASE STRAIGHT DA GUIDE SHEATH (GS9095SD / 31411442) AND THERE WAS AN OOZING OF BLOOD AT THE LUER HUB. THE CEREBASE WAS IMMEDIATELY WITHDRAWN. ADDITIONALLY, IT WAS REPORTED THAT THE EXTENSION OF THE HEMOSTATIC VALVE INCLUDED WITH THE PACKAGING COULD NOT BE FULLY TIGHTEN AND WILL SLIP. IT WAS ONLY SECURE AFTER IT WAS REPLACED WITH ANOTHER SHORT HEMOSTATIC VALVE FROM A COMPETITOR BRAND. THE PHYSICIAN REPLACED THE CEREBASE WITH A NEW DEVICE FROM A COMPETITOR BRAND TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT FILE. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO. ON 04-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE INTENDED PROCEDURE WAS A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE. THIS WAS NOT AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) CASE; THE DEVICE WAS NOT SNAKED (ADVANCED WITHOUT WIRE/MICROCATHETER). THE DEVICE DID NOT END UP BECOMING FRACTURED INTO TWO PIECES. THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339749 ↗
• MalfunctionJan 23, 2025Crack; Crack

  AS REPORTED BY THE FIELD, THE HUB OF A CEREBASE STRAIGHT DISTAL CATHETER (GS9095SD, 31395244) WAS BROKEN. THE DEVICE WAS NOT CLINICAL USED. THE PACKAGING LOOKED NORMAL, NO DAMAGE OF PACKAGING VISIBLE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218213 ↗
• MalfunctionDec 2, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DAMAGE WAS NOTED UPON OPENING IN THE TWO 95CM CEREBASE DA GUIDE SHEATH (GS9095SD) FROM THE SAME LOT NUMBER (31347438). THERE WAS NO NEGATIVE PATIENT IMPACT. ON 08-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE DISTAL TIP WAS DAMAGED ON BOTH CEREBASE DEVICES. THE REPORTED ISSUE DID NOT RESULT IN ANY DELAY IN THE PROCEDURE. THERE WAS NO DIFFICULTY IN REMOVING THE DEVICES FROM THEIR RESPECTIVE PACKAGING. THERE WAS NO DAMAGE NOTED ON THE PACKAGING OF THE DEVICES. THE DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSES COMPLETED ON 29-NOV-2024, ONE OF THE CEREBASE WAS NOTED TO HAVE A FRACTURE BUT WAS NOT COMPLETELY SEPARATED. THE OBSERVED FINDING MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827498 ↗
• MalfunctionJun 5, 2024Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A CRACK NOTED ON THE 95CM CEREBASE DA GUIDE SHEATH (GS9095SD / 31045395) UPON OPENING THE PACKAGE. THE ISSUE WAS NOTED PRE-OP; THERE WAS NO PATIENT INVOLVEMENT. ON 29-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE CRACK WAS OBSERVED AT THE PROXIMAL END, DISTAL TO THE HUB. NOTHING UNUSUAL WAS NOTED ON THE DEVICE PACKAGING. THE DEVICE WAS REPLACED WITH ANOTHER 95CM CEREBASE DA GUIDE SHEATH (GS9095SD). THE REPORTED ISSUE DID NOT RESULT IN ANY DELAY IN THE PROCEDURE. THE INFORMATION ALSO INDICATED THAT THE DEVICE PACKAGING IS AVAILABLE FOR RETURN. ON 31-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE REPORTED DEVICE DAMAGE WAS NOTICED BEFORE REMOVING THE DEVICE FROM THE PACKAGE. THE DEVICE WAS NOT REMOVED FROM THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473149 ↗
• MalfunctionFeb 20, 2024Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 95CM CEREBASE DA GUIDE SHEATH (GS9095SD / 31154812) BROKE. THERE WAS NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. ON 13-FEB-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A CEREBRAL THROMBECTOMY TARGETING THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE VESSEL WAS EXCESSIVELY TORTUOUS WITH ACUTE BENDS. THIS WAS NOT AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) CASE; THE DEVICE WAS NOT SNAKED (ADVANCED WITHOUT WIRE / MICROCATHETER). THE CEREBASE DID NOT BECOME FRACTURED INTO TWO SEPARATE PIECES. THE DEVICE WAS NOT REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE INFORMATION INDICATED THAT THE CONCOMITANT EMBOVAC LARGE BORE CATHETER HAD ¿SEVERE LENGTHENING AND DEFORMATION OF THE EMBOVAC DURING THE RETRIEVAL MANEUVER DUE TO KINKING OF THE CEREBASE GUIDING CATHETER.¿ A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744745 ↗
• MalfunctionFeb 20, 2024Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 95CM CEREBASE DA GUIDE SHEATH (GS9095SD / 31168613) WAS USED DURING THE ENTIRE THROMBECTOMY CASE; THE PATIENT IS CONSIDERED TO HAVE MODERATE VESSEL TORTUOSITY. THE PHYSICIAN USED THE CEREBASE WITHOUT ANY ISSUE. IT WAS REPORTED THAT AS HE WAS REMOVING THE CEREBASE FROM THE PATIENT¿S BODY, THE CEREBASE FRACTURED ALMOST COMPLETELY. THE PHYSICIAN ALLOWED THE SYSTEM TO RELAX AND REMOVED THE ENTIRE CEREBASE CATHETER THROUGH THE SHEATH IN THE RIGHT FEMORAL ARTERY. THERE WAS NO VESSEL DISSECTION AND NO FOREIGN BODY REMAINING IN THE PATIENT. THERE WAS NO NEGATIVE PATIENT IMPACT. THE GROIN WAS CLOSED NORMALLY. NO SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740549 ↗
• MalfunctionFeb 14, 2024Material Separation; Material Separation

  AS REPORTED BY THE FIELD, A CEREBASE GUIDE CATHETER (GS9090SD, (B)(6)) BROKE/SEPARATED AT THE DISTAL END WHERE THE CONNECTION BETWEEN POLYMERS IS. IT DID NOT SEPARATE AS THE BRAIDING WAS HOLDING EVERYTHING TOGETHER. THERE WAS NO DAMAGE TO THE PATIENT. THE PRODUCT WAS EXCHANGED FOR NEW CEREBASE AND THE PROCEDURE WAS FINISHED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701610 ↗
• MalfunctionFeb 13, 2024Crack; Crack

  AS REPORTED BY THE FIELD, A CEREBASE GUIDE CATHETER (GS9095SD, 31150970) WAS NOTED WITH A LARGE KINK AND BROKEN CATHETER WHEN IT CAME OUT OF THE PACKAGING . THEY SUSPECT THE DAMAGE HAS COME FROM TRANSPORT OR HANDLING OF THE BOXES. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JAN-2024 INDICATED THAT IT WAS DIFFICULTY REMOVING THE DEVICE FROM PACKAGING. THERE WAS NO CATHETER SEPARATION. AFTER REVIEW OF PICTURE RECEIVED ON 23-JAN-2024, A CRACKED CONDITION WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696435 ↗
• MalfunctionJan 31, 2024Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR PROCEDURE, THE 95CM CEREBASE DA GUIDE SHEATH ((B)(6)) BROKE INSIDE THE PATIENT. A LEAKAGE OF CONTRAST MEDIUM OCCURRED AT THE FRACTURE SITE. IT WAS REPORTED THAT OTHER VESSELS THAT WERE NOT PART OF THE TARGET VISUALIZATION WERE ALSO VISUALIZED. THE CATHETER WAS REPLACED. THERE WAS LOSS OF CONTRAST MEDIUM AND TIME. THE PROCEDURE WAS DELAYED; THE DURATION OF THE DELAY WAS NOT REPORTED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 31-JAN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE INTENDED PROCEDURE WAS AN ELECTIVE ANEURYSM TREATMENT PROCEDURE. IT WAS NOT AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) CASE; THE DEVICE WAS NOT SNAKED (ADVANCED WITHOUT MICROWIRE / MICROCATHETER). THE VESSEL WAS NOT EXCESSIVELY TORTUOUS NOR WITH ACUTE BENDS. THE DEVICE DID NOT FRACTURE INTO TWO SEPARATE PIECES; IT WAS ¿ONLY A TEAR WITHOUT SEPARATION.¿ THE REPLACEMENT CATHETER WAS ANOTHER CEREBASE ((B)(6)). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NEW REPLACEMENT CATHETER. THERE WAS A 5-MINUTE DELAY THAT THE PHYSICIAN DID NOT DEEM CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616690 ↗
• DeathJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE, THE INTERNAL CAROTID ARTERY (ICA) WAS BLOCKED WITH A LARGE CLOT, THEREFORE, THE PHYSICIAN ASPIRATED DIRECTLY FROM THE 95CM CEREBRALS DA GUIDE SHEATH (GS9095SD / 31108261) AS IT WAS ABLE TO TRACK TO THE CLOT LOCATION. AT THE COMPLAINT INITIATION, THE NUMBER OF PASSES IS NOT KNOWN, BUT IT WAS REPORTED THAT A LARGE CLOT WAS RETRIEVED THROUGH THE CEREBASE DA. IT WAS THEN REPORTED THAT ¿AFTER DOING A RUN TO CHECK CLEARANCE, THE VESSEL HAD PERFORATED. THE PHYSICIAN IS NOT PLACING BLAME ON THE DEVICE. ADDITIONAL INFORMATION IS PENDING. THERE IS ONE PHOTO OF THE DEVICE AND ONE PROCEDURE IMAGE INCLUDED IN THE COMPLAINT. THEY ARE PENDING INDEPENDENT PHYSICIAN REVIEW.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 18585253 ↗
• MalfunctionDec 4, 2023Crack; Crack

  AS REPORTED BY THE FIELD, THE HUB OF A CEREBASE GUIDE CATHETER DISTAL ACCESS (GS9095SD, 31032673), THE CONNECTION BETWEEN HUB AND CATHETER WAS BROKEN WHEN IT WAS FIRST OPEN. THE PHYSICIAN USED THE SAME-LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY DONE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256063 ↗
• MalfunctionSep 14, 2023Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY FOR AN ISCHEMIC STROKE, THE COMPLAINT DEVICE, A 95CM CEREBASE DA GUIDE SHEATH (GS9095SD/31024631) WAS REPORTED AS HAS BEEN BROKEN IN THE HUB CONNECTION (PROXIMAL PART), CAUSING A LEAK OF SALINE TO FLOW OUTSIDE THE CATHETER. IT COULD NOT BE USED TO CONTINUE THE PROCEDURE AND WAS REMOVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750259 ↗
• MalfunctionFeb 6, 2023Crack; Crack

  AS REPORTED BY THE FIELD, DURING THE PREPARATION OF THE 95CM CEREBASE CATHETER (GS9095SD, 30954434) THE TECHNOLOGIST NOTED A LEAK IN THE SUPPORT ZONE OF THE CATHETER WHILE FLUSHING WITH HEPARINIZED SALINE. THE TECHNOLOGIST REPORTED THE CRACK IN THE CATHETER TO THE PHYSICIAN AND A NEW 95CM CEREBASE WAS USED. THERE WAS NO PATIENT INVOLVEMENT AS ALL OF THIS OCCURRED ON THE BACK TABLE WHERE ALL CATHETERS AND DEVICES ARE PREPARED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO RE-SHAPING OF THE DEVICE ONCE REMOVED FROM THE PACKAGE. THE CEREBASE WAS LAID OUT ON STRAIGHT ON THE BACK TABLE DURING THE PREPARATION OF THE CATHETER. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICE DURING PREPPING. THERE WAS NO DIFFICULTY FLUSHING THE DEVICE, BUT THE TECHNOLOGIST NOTICED SALINE COMING OUT THE CATHETER JUST DISTAL TO THE CATHETER HUB. THE TECHNOLOGIST INSPECTED THE CATHETER AND NOTICED THE CRACK IN THE CEREBASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305597 ↗
• MalfunctionJan 23, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED BY THE FIELD, THE PACKAGING OF A CEREBASE 95CM CATHETER (GS9095SD, 30947381) WAS CRUSHED DURING SHIPMENT, COMPROMISING THE INTEGRITY OF THE STERILE PACKAGING, CATHETER, AND ACCESSORY DEVICES. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE DEVICE WAS NEVER USED AND WAS RECEIVED BY THE LAB IN THE CONDITION DESCRIBED ABOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229921 ↗
• MalfunctionJan 17, 2023Crack; Crack

  AS REPORTED BY THE FIELD, A CEREBASE DA CATHETER (GS9095SD, 30789642) PROXIMAL HUB WAS KINKED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185156 ↗
• MalfunctionJan 6, 2023Crack; Crack

  AS REPORTED BY THE FIELD, THE CEREBASE DA CATHETER (GS9095SD / LOT: 30789642) PROXIMAL HUB WAS KINKED BEFORE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT IS UNKNOWN IF THE DAMAGE OCCURRED DURING THE PREPPING OF THE DEVICE. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112517 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNKNOWN PROCEDURE USING A STRAIGHT DISTAL CEREBASE DA GUIDE SHEATH, 90, 95CM (GS9095SD/LOT UNKNOWN) EXPERIENCED A VASCULAR DISSECTION OCCURRING AT AN UNKNOWN VESSEL LOCATION BY ACTION OF THE CEREBASE DA DISTAL TIP. THERE WAS NO REPORT OF A SURGICAL DELAY OR ANY PATIENT CONSEQUENCE. PROCEDURAL IMAGES WERE RETURNED FOR ANALYSIS AND WILL BE FORWARD FOR REVIEW BY THE SR. MEDICAL AFFAIRS DIRECTOR, NEUROINTERVENTIONALIST. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: Vascular Dissection

  MAUDE report 16042036 ↗