CEREGLIDE NIC71132URecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886704085409), received between Dec 12, 2023 and May 5, 2026 — classified as 1 death, 17 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STROKE PROCEDURE, THE PHYSICIAN USED A 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31668075) THROUGH A ZOOM¿88 ASPIRATION CATHETER (IMPERATIVE CARE). BOTH CATHETERS WERE WELL-HYDRATED (FLUSHED), THE CEREGLIDE REPORTEDLY GOT STUCK IN THE ZOOM 88. DURING THE ADVANCEMENT OF THE CEREGLIDE 71 CATHETER, THE PHYSICIAN REPORTED THAT IT FELT TIGHT AND AS A RESULT, THE PHYSICIAN REMOVED IT AND THE CEREGLIDE 71 CATHETER STRETCHED. THE PHYSICIAN TRIED THE SECOND CEREGLIDE, A 137 CM CEREGLIDE 71 CATHETER (NIC71137U / 31684676). EVERYTHING FLUSHED WELL BUT THE SAME ISSUE WAS ENCOUNTERED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAY-2026. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY. THE TARGET VESSEL WAS NOT EXCESSIVELY TORTUOUS. THE SECOND CEREGLIDE CATHETER WAS ALSO USED WITH THE ZOOM 88. THE INFORMATION INDICATED THAT FOR BOTH CEREGLIDE CATHETERS, THE ISSUE OCCURRED ON THE FIRST PASS. AFTER THE SECOND CEREGLIDE CATHETER, THE PHYSICIAN USED A ZOOM 7MM X 137MM TO COMPLETE THE PROCEDURE. THE ZOOM 88 WAS ALSO USED TO COMPLETE THE PROCEDUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086314 ↗
• MalfunctionApr 3, 2026Failure to Advance; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE ON (B)(6) 2026, A ¿.071 X 132CM CEREGLIDE 71 WAS USED AND ¿THE CATHETER STRETCHED AFTER OUR FIRST PASS AND THE DOCTOR WOULD LIKE IT REPLACED.¿ THERE WAS NO HARM TO THE PATIENT AND THERE WAS NO DELAY TO THE PROCEDURE. ON (B)(6) 2026, THE CLINICAL ACCOUNT SPECIALIST FOLLOWED UP WITH THE SITE AND GOT THE FOLLOWING ADDITIONAL INFORMATION: ¿THE PHYSICIAN TOLD ME THAT THE [CEREGLIDE] CATHETER COULD NOT GO THROUGH THE BALLAST GUIDE CATHETER. [PER THE SURGICAL TECH], THE CATHETER WAS STRETCHED UPON REMOVAL DURING THE FIRST PASS ASPIRATION. PHYSICALLY, THE CATHETER DOES NOT LOOK STRETCHED BY VISIBLE SITE.¿ THE INFORMATION INDICATED THAT THE DEVICE USED WAS A 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31679894). THERE WAS NO BREAK IN THE DEVICE INTEGRITY. THE PROCEDURE WAS TARGETING AN OCCLUSION IN THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY (ICA); SOME CALCIFICATION WAS NOTED. THE PROCEDURE WAS AN ADAPT ((DIRECT ASPIRATION FIRST PASS TECHNIQUE) CASE, BUT THE ASSOCIATED TRAK® MICROCATHETER (STRYKER) WAS NOT ¿SNAKED.¿ A SYNCHRO ¿ 14 GUIDEWIRE (STRYKER) WAS ALSO USED. RECANALIZATION WAS NOT ACHIEVED ON THE FIRS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783446 ↗
• MalfunctionMar 18, 2026Retraction Problem; Stretched; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, A 132CM CEREGLIDE 71 CATHETER (PRODUCT CODE: NIC71132U, LOT NUMBER: 31684675) WOULD NOT GO BACK INTO THE GUIDE CATHETER AFTER THE FIRST PASS. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 13-MAR-2026 INDICATED THAT THE CONCOMITANT DEVICE WAS INTACT. THE RESISTANCE DID OCCUR WHEN PUSHING IT THROUGH THE GUIDE CATHETER, BUT NO DAMAGE WAS SEEN ON THE GUIDE CATHETER. THE CEREGLIDE CATHETER DID APPEAR STRETCHED/KINKED. THE CATHETER WAS PULLED OUT ONCE RESISTANCE WAS FELT. NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER CEREGLIDE AND THE PROCEDURE CONTINUED. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628322 ↗
• MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A HEALTHCARE PROFESSIONAL REPORTED THAT CONTRAST MEDIA WAS LEAKED OUT FROM THE DISTAL PART OF A 132CM CEREGLIDE 71 CATHETER (NIC71132U, 31434338). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534243 ↗
• MalfunctionSep 19, 2025Crack; Crack

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT THIS WAS A MECHANICAL THROMBECTOMY TO TREAT A STROKE IN THE RIGHT PRIMARY MOTOR CORTEX (RM1) REGION. THE HUB OF A 132CM CEREGLIDE 71 CATHETER (NIC71132U, 31395153) CRACKED AFTER MULTIPLE USES. IT WAS REPLACED WITH ANOTHER CEREGLIDE 71 132CM (C71) CATHETER AND PROCEDURE WAS FINISHED. ACCESS WAS MADE FROM THE FEMORAL ARTERY. THE CEREGLIDE 71 CATHETER WAS USED A 6 AS WELL.5X45CM EMBOTRAP. THE TECHNOLOGIST BELIEVES ONE PASS WAS MADE WITH THE C71 ASPIRATION ONLY AND THEN ONE PASS WITH EMBOTRAP AND SOME CLOTS WERE REMOVED. WHEN ATTEMPTING THIRD PASS PRIOR TO USING- HUB WAS NOTICED LEAKING SO IT WAS REMOVED AND BAGGED. A NEW C71 WAS USED ON NEXT ASPIRATION PASS AND VESSEL WAS OPEN WITH GOOD RESULTS AND PATIENT DOING WELL. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-SEP-2025 INDICATED THAT THERE WAS NO ALLEGED PRODUCT MALFUNCTION WITH THE EMBOTRAP, HOWEVER, NOT ALL THE CLOT WAS CAPTURED. THE HUB CRACK WAS NOTED WHEN THE USER WAS GOING TO DO ANOTHER ASPIRATION ATTEMPT WITH CATHETER FOLLOWING EMBOTRAP PASS. IT WAS FURTHER NOTED THAT WHEN GETTING PREPARED TO DO ANOTHER PASS WITH C71 OUTSIDE THE BODY NOTICE LEAKING OF SALINE FROM HUB/STRAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097096 ↗
• MalfunctionSep 8, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, AN ENVOY 6F WAS USED TO SEE WHAT THE OCCLUSION LOOKED LIKE, THEN IT WAS SWITCHED TO A 95CM CEREBASE (PRODUCT, LOT NUMBER UNKNOWN) AND A 132CM CEREGLIDE 71 CATHETER (NIC71132C, LOT UNKNOWN), GLIDING, NO MICROCATHETER, NO WIRE. THEN ASPIRATION WAS UNSUCCESSFUL (DUE TO STENOSIS BEHIND IT). THEN A TRANSEND¿ GUIDEWIRE AND A REBAR 27 MICROCATHETER WERE INSERTED UP AND A 6X40 SOLITAIRE¿ REVASCULARIZATION DEVICE WAS USED. THEN, EVERYTHING WAS REMOVED TOGETHER AND OUTSIDE THE PATIENT, IT WAS DISCOVERED THAT THE DISTAL END OF THE CEREGLIDE WAS FLATTENED. THEN SWITCHED TO SOFIA 5F AND STENT RETRIEVER (ALSO UNSUCCESSFUL), THEN FINALLY WITH CEREBASE UP AND DIRECT ASPIRATION IT WAS SUCCESSFUL. BUT THE PATIENT KEPT FORMING THROMBI (VERY QUICKLY). THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992929 ↗
• MalfunctionSep 3, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY, WITH A 132CM CEREGLIDE 71 CATHETER (NIC71132U, 31347322). THE PHYSICIAN COMPLETED FIRST PASS, REMOVED AND CLEANED THE CEREGLIDE AND BEFORE RE-INSERTING THE CATHETER FOR A SECOND PASS NOTICED A ¿CRIMP¿ APPROX. 10CM PROXIMAL TO THE DISTAL TIP OF THE CATHETER. HE COMPLETED THE PROCEDURE WITH A DIFFERENT CATHETER. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-AUG-2025 INDICATED THAT THE TARGET VESSEL/SITE WAS AN OCCLUSION AT THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). IT WAS FURTHER CLARIFIED THAT THE CATHETER HAD A ¿FLATTENED¿ KINK ABOUT 10CMS FROM DISTAL TIP. NORMAL ANATOMY WAS NOTED. THE PHYSICIAN EXPECTED THAT IT HAPPENED IN THE RHV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954915 ↗
• MalfunctionJul 31, 2025Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31335786) WAS KINKED ON THE TIP AREA WHEN THE DEVICE WAS FIRST OPENED. THE PHYSICIAN USED ANOTHER 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U) FOR THE PROCEDURE AND IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. BASED ON THE PRODUCT INVESTIGATION COMPLETED ON 31-JUL-2025, THE ISSUE REPORTED HAS BEEN DETERMINED TO BE REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683468 ↗
• MalfunctionJul 15, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY OF THE INTERNAL CAROTID ARTERY TO TREAT ACUTE ISCHEMIC STROKE, A 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31457321) WAS FOUND TO BE KINKED. THERE WAS NO REPORTED NEGATIVE IMPACT ON THE PATIENT WAS REPORTED. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE OPTIMO 8F BALLOON CATHETER AND A PHENOM MICROCATHETER. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 10-JUL-2025 INDICATING THAT THE KINKED OCCURRED IN THE PATIENT PRIOR TO ASPIRATION OR DELIVERING STENT RETRIEVER. THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO DIFFICULTY IN REMOVING THE DEVICE FROM PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508728 ↗
• MalfunctionJul 8, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE MID BODY OF A 132CM CEREGLIDE 71 CATHETER (NIC71132U, 31364334) WAS KINKED WHEN OVERCOME SEGMENT M1, DISTAL PART. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436928 ↗
• MalfunctionJul 8, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY, M1SEGMENT TO TREAT ACUTE ISCHEMIC STROKE. THE 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31491254) WAS ATTEMPTED TO BE USED TO RETRIEVE A THROMBUS AT THE MIDDLE CEREBRAL ARTERY M1. DURING DELIVERY OF THE CEREGLIDE 71, IT GOT KINKED AT THE ROOT SECTION AND BECAME UNUSABLE. THE CEREGLIDE 71 WAS REPLACED WITH ANOTHER NEW ASPIRATION CATHETER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUN-2025 INDICATED THAT THERE WAS NO ADDITIONAL INTERVENTION NEEDED TO REMOVE THE DEVICE FROM THE PATIENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-JUL-2025 INDICATED THAT THE DEVICE HAD BEEN ADVANCED OR WITHDRAWN AGAINST RESISTANCE, NO FURTHER DETAILS ARE AVAILABLE. THERE WERE NO PROCEDURAL PROLONGATION/DELAY DUE TO THE EVENT. AORTA WAS TYPE 3 (RELATIVE SEVERE TORTUOSITY AT BRANCH). NO CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436397 ↗
• MalfunctionJun 10, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE BOX OF AN 132CM CEREGLIDE 71 CATHETER CG71 (NIC71132U, 31191775) WAS SEALED AND WAS GOING TO BE USED IN A CLINICAL SETTING, THIS WAS A TRUNK STOCK PRODUCT. WHEN THE BOX WAS OPENED AND STERILE PACKAGE PULLED OUT, STAFF NOTICED THE STERILE PACKAGE WAS OPENED AND UNABLE TO BE USED. THE SURGERY WAS DELAYED BY ONE MINUTE. A SECOND DEVICE WAS OPENED AND USED; THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-JUN-2025 INDICATED THAT THERE WERE NO PICTURES TAKEN OF THE STERILE PACKAGE BEING OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176438 ↗
• MalfunctionMay 8, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A THROMBECTOMY PROCEDURE, A 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U, LOT UNKNOWN) WAS TIGHT INSIDE THE SHUTTLE GUIDE SHEATH. WHEN THE USER PULLED OUT THE CEREGLIDE 71 INTERMEDIATE CATHETER, THE BASE CATHETER HAD BEEN DRAG INTO THE AORTA, PREVENTING THE USER FROM GETTING THE FINAL IMAGES. THERE WERE NO PROCEDURAL DELAYS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-MAY-2025 INDICATED THAT THERE WAS RESISTANCE BETWEEN THE CEREGLIDE AND THE SHUTTLE. THE DEVICE DID NOT KINK OR BENT PRIOR TO THE EVENT. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO ADDITIONAL INTERVENTION. AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. IT WAS NOTED BY THE PHYSICIAN, THAT WHEN USING THE CEREGLIDE, THE REPORTED EVENT IS PREDICTABLE AS THESE PATIENTS OFTEN HAVE MORE RIGID ARTERIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987720 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT REGARDING CLINICAL TRIAL EXCELLENT (B)(4) REVIEWED. A CEREGLIDE71 IC 71, 132 CM, US (NIC71132U/ 31232322) WAS USED DURING A MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT EXPERIENCED THE EVENT OF ¿LEFT M1 RE-OCCLUSION,¿ WHICH WAS ASSESSED BY THE PI AS A SERIOUS, SEVERE ADVERSE EVENT, AND AS UNRELATED TO THE STUDY DEVICE, UNRELATED TO THE LARGE BORE CATHETER, UNRELATED TO THE CEREGLIDE71, AND UNRELATED TO THE PRIMARY SURGICAL PROCEDURE. THE EVENT REQUIRED THE SURGICAL INTERVENTION OF A ¿SUCCESSFUL TICI 2C EMBOLECTOMY.¿ THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING,¿ WITH NO END DATE LISTED. ADDITIONAL INFORMATION WAS RECEIVED ON 28-MAR-2024 TO FURTHER CLARIFY THE SERIES OF EVENTS THAT LED UP TO TWO PROCEDURES IN ONE DAY. THE INFORMATION RECEIVED IS AS FOLLOWS, ¿THE SUBJECT INITIALLY PRESENTED AND RECEIVED TENECTEPLASE (TNK) WITH NIHSS SCORE WAS OF 4. EMBOLECTOMY WAS PERFORMED WITH THE CEREGLIDE AND A TICI 3 WAS ACHIEVED AFTER TWO PASSES. RIGHT AFTER ACCESS CLOSURE, THE SUBJECT EXPERIENCED NEUROLOGICAL DECLINE AND WAS FOUND TO REOCCLUDE AT M1 OF THE MCA. THE INVESTIGATOR PERFORMED ANOTHER EMBOLECTOMY PROCEDURE, AND HE DID NOT USE THE CEREGLIDE

  Patient problems: Vascular Dissection

  MAUDE report 21881540 ↗
• MalfunctionMar 24, 2025Crack; Material Puncture/Hole; Retraction Problem; Material Deformation; Crack; Material Puncture/Hole; Retraction Problem; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A 132CM CEREGLIDE 71 CATHETER (NIC71132U, 31395153) COLLAPSED AND SEPARATED/SHREDDED DURING THROMBECTOMY PROCEDURE. THERE WAS DIFFICULTY REMOVING THE CATHETER FROM AXS INFINITY AFTER SUCTION. REMOVED AND DISCOVERED THE ISSUE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677825 ↗
• MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THERE WAS LEAKAGE AT THE HUB AREA OF THE 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31352613). THE PHYSICIAN REPLACED IT WITH A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370471 ↗
• MalfunctionJan 29, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, DURING A THROMBECTOMY FOR AN INTERNAL CAROTID ARTERY TO TREAT ACUTE ISCHEMIC STROKE, A 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31335785) WAS INSERTED INTO THE PATIENT¿S BODY AS USUAL MANNER. THE PHYSICIAN FOUND BLOOD RETURN FROM THE CATHETER HUB IN TIME WITH THE PATIENT'S HEARTBEAT. THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY AND WAS FOUND TO BE TORN AT THE HUB. THE CATHETER WAS REPLACED WITH THE OTHER COMPANY¿S CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ISSUE WAS FOUND PRIOR TO USE THE CEREGLIDE 71, SO THE PROBLEM SEEMED TO BE ON THE PRODUCT ITSELF. NO ADDITIONAL INTERVENTION SUCH AS BLOOD TRANSFUSIONS HAD BEEN PERFORMED FOR THE BLOOD LEAKAGE. ALSO, NO OTHER EVENTS RELATED TO THE PATIENT'S CONDITION HAVE OCCURRED. THE DEVICE WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE CHIKAI14 GUIDEWIRE AND A PHENOM MICROCATHETER (MC). ADDITIONAL EVENT INFORMATION RECEIVED ON 29-JAN-2025 INDICATED THAT THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264312 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 74-YEAR-OLD MALE PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION, AND PREVIOUS SMOKER, PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. THE LAST TIME HE WAS SEEN WELL WAS ON (B)(6) 2024 AT 06:00 HOUR. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2024, AT 08:00 HOUR. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 12:54 HOUR. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 9 AND A MRS SCORE OF ¿0-NO SYMPTOMS.¿ THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2024. A 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31319275) WAS USED TARGETING AN OCCLUSION IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE FIRST PASS WAS MADE USING THE CEREGLIDE71 DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN A MTICI SCORE OF 2A, WITH NO CLOT RETRIEVAL. DUE TO PERSISTENT CLOT, DEVICES WERE EXCHANGED, AND THE SECOND PASS WAS MADE USING AN AXS CATALYST® 5

  Patient problems: Intracranial Hemorrhage

  MAUDE report 21105820 ↗
• MalfunctionJan 7, 2025Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31335786) WAS KINKED AT 3CM FROM THE HUB. NO NEGATIVE PATIENT IMPACT WAS REPORTED. ONE PHOTO WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097785 ↗
• MalfunctionDec 26, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, ¿WE HAD TWO CEREGLIDE CATHETERS WHERE THE HUBS WERE CRACKED ¿ DRAWING AIR.¿ THE TWO 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U) WERE FROM TWO DIFFERENT LOTS: THE FIRST CEREGLIDE IS FROM LOT 31303031 AND THE SECOND CEREGLIDE IS FROM LOT 31411523. THERE WAS NO REPORT OF ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020004 ↗
• MalfunctionDec 26, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, ¿WE HAD TWO CEREGLIDE CATHETERS WHERE THE HUBS WERE CRACKED ¿ DRAWING AIR.¿ THE TWO 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U) WERE FROM TWO DIFFERENT LOTS: THE FIRST CEREGLIDE IS FROM LOT 31303031 AND THE SECOND CEREGLIDE IS FROM LOT 31411523. THERE WAS NO REPORT OF ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020001 ↗
• MalfunctionDec 12, 2024Crack; Crack

  AS REPORTED BY THE FIELD, AN132CM CEREGLIDE 71 CATHETER (NIC71132C, 31364341) WAS BROKEN AT THE HUB AFTER OPENING THE BOX. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-DEC-2024 INDICATED THAT THERE WERE NO PACKAGING ISSUES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916380 ↗
• MalfunctionDec 10, 2024Retraction Problem; Retraction Problem

  AS REPORTED BY THE FIELD, THIS WAS A MECHANICAL THROMBECTOMY OF THE RIGHT MIDDLE CEREBRAL ARTERY, SEGMENT M1 OCCLUSION. AFTER APPROACHED BRANCHOR 8FR AS A GUIDING CATHETER TO RIGHT INTERNAL CAROTID ARTERY VIA RIGHT FEMORAL ACCESS, A TRAK21 MICROCATHETER (MC) AND A SYNCRO14 GUIDEWIRE WAS ADVANCE INTO THE LESION. THEN THE 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31404529) WAS INSERTED. WHEN THE THROMBUS WAS GRASPED AND ATTEMPTED TO BE REMOVED, THERE WAS SOME RESISTANCE INSIDE THE BRANCHOR. THE CEREGLIDE71 WAS REMOVED AS IT WAS, AND RECANALIZATION WAS ACHIEVED BY THE FIRST PASS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS RIGHT MIDDLE CEREBRAL ARTERY M1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20896293 ↗
• InjuryDec 10, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A 132CM CEREGLIDE 71 CATHETER (NIC71132C/ 31287913) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED DIFFICULTY ADVANCING THE CEREGLIDE71 CATHETER TO THE SITE OF OCCLUSION BUT WAS UNSUCCESSFUL DUE TO CHALLENGING ANATOMY. A TRAK MICROCATHETER (STRYKER) AND A SOLITAIRE STENT RETRIEVER (MEDTRONIC) WAS USED AND ¿THE THROMBUS WAS RETRIEVED BY COMBINED TECHNIQUE.¿ AFTER THE FIRST PASS, ANGIOGRAPHY REVEALED THAT RECANALIZATION WAS NOT ACHIEVED. FOR THE SECOND PASS, THE CEREGLIDE WAS REPLACED WITH ESPERANCE 5FR (WALLABY MEDICAL). THE ESPERANCE 5FR COULD NOT BE ADVANCED FROM C1, EITHER. SO, AGAIN, THE MICROCATHETER CROSSED THE LESION AND SOLITAIRE (4×40) WAS DEPLOYED. THE DEVICES WERE RETRIEVED BY COMBINED TECHNIQUE. AFTER THE SECOND PASS, ANGIOGRAPHY REVEALED RECANALIZATION WAS NOT ACHIEVED, AND BLEEDING WAS OBSERVED. SUBSEQUENTLY, HEMOSTASIS WAS CONFIRMED, AND THE PROCEDURE WAS TERMINATED WITH TICI SCORE OF 0 (NO PERFUSION). ¿THE PHYSICIAN COMMENTED THAT THE PATIENT HAD BEEN LEFT-SIDED HEMIPARESIS SINCE THE ONSET OF TH

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

  MAUDE report 20893518 ↗
• MalfunctionDec 9, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PROXIMAL HUB OF THE 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31364334) WAS BROKEN AND BLOOD LEAKED OUT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20884548 ↗