BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEREGLIDE

    MDR report key: 23439970 · Received October 31, 2025

    Report

    Report Number
    3007628272-2025-00053
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 12, 2025
    Manufacturer
    CERENOVUS, INC.
    Product Code
    QJP
    UDI-DI
    10886704086024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). THE PROCEDURE IMAGES ARE STILL PENDING INDEPENDENT PHYSICIAN REVIEW. THE TWO PHOTOS OF THE DEVICE INCLUDED IN THE COMPLAINT WERE REVIEWED BY THE PRODUCT ANALYSIS TEAM. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: THE PHOTOS SHOW THE DISTAL END OF THE CEREGLIDE 92 CATHETER IN A SEVERELY FLATTENED AND COLLAPSED CONDITION. NO ADDITIONAL DAMAGES CAN BE SEEN. THE ISSUE REPORTED REGARDING THE DAMAGED CEREGLIDE CATHETER IS CONFIRMED. IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTOS PROVIDED, AND ACCORDING TO THE AVAILABILITY, THIS DEVICE HAS BEEN DISCARDED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31747750) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO INTERNAL ACTIONS RELATED TO DEVICE MANUFACTURE OR INSPECTION. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND / OR DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THROMBOEMBOLISM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE CEREGLIDE92 INTERMEDIATE CATHETER AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE EVENT WAS SUSPECTED TO BE CAUSED BY ADVANCING THE CEREGLIDE92 CATHETER INTO THE DISTAL M1 SEGMENT, PUSHING THE CLOT DISTALLY. THE IFU INSTRUCTS THAT THE CATHETER IS TO BE CAREFULLY ADVANCED UNDER FLUOROSCOPIC GUIDANCE WHILE MAINTAINING ASPIRATION SO THAT THE EMBOLI OR THROMBI REMAINS FULLY ENGAGED WITH THE DISTAL TIP OF THE CATHETER. HOWEVER, IT WAS ALSO REPORTED THAT THE CEREGLIDE92 CATHETER WAS FOUND TO BE ¿COLLAPSED/FLATTENED¿ UPON REMOVAL FROM THE PATIENT AFTER THE SECOND PASS; CATHETER DEFORMATION / DAMAGE MAY INHIBIT THE ASPIRATION FUNCTION, REQUIRING THE DEVICE TO BE REPLACED. CLINICAL AND PROCEDURAL FACTORS, INCLUDING CLOT BURDEN (I.E., FIBROUS CLOT), VESSEL CHARACTERISTICS (I.E., TORTUOSITY), AND MECHANICAL MANIPULATION OF DEVICES, MAY HAVE CONTRIBUTED TO THE EVENTS. SINCE A THROMBOEMBOLISM IS CONSIDERED A SERIOUS INJURY WHICH NECESSITATES INTERVENTION/TREATMENT, AND THE CORRELATION BETWEEN EVENT TO THE USED CEREGLIDE92 CATHETER AS A CONTRIBUTING FACTOR CANNOT BE RULED OUT, THIS EVENT DOES MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ REGARDING THE EVENT OF AN ARTERIAL SPASM, THERE IS NO EVIDENCE TO SUGGEST THIS EVENT WAS ATTRIBUTED TO THE CEREGLIDE92 CATHETER. THE SPASM OCCURRED AT THE TIP OF THE ARROW LONG GUIDE SHEATH, WHICH WAS SITTING ON A BEND/CURVE WITHIN THE INTERNAL CAROTID ARTERY. ARTERIAL SPASM, OR THE TEMPORARY TIGHTENING OF THE MUSCLES IN THE VESSEL WALL, IS KNOWN TO RESULT FROM VESSEL WALL IRRITATION. THE SPASM WAS LIKELY DUE TO THE SHEATH BEING PLACED IN DIRECT CONTACT WITH THE VESSEL WALL. FURTHER, THE SPASM WAS TRANSIENT AND RESOLVED WITHOUT INTERVENTION. THEREFORE, THIS EVENT DOES NOT MEET US FDA REPORTING CRITERIA. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. REFERENCE: PILGRAM-PASTOR SM, PIECHOWIAK EI, DOBROCKY T, KAESMACHER J, DEN HOLLANDER J, GRALLA J, MORDASINI P. STROKE THROMBECTOMY COMPLICATION MANAGEMENT. J NEUROINTERV SURG. 2021 OCT;13(10):912-917. DOI: 10.1136/NEURINTSURG-2021-017349. EPUB 2021 JUN 22. PMID: 34158401; PMCID: PMC8458081. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED LATER. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE MEDICAL IMAGE REVIEW COMPLETED ON (B)(6) 2025. THE PROCEDURE IMAGES THAT WERE INCLUDED IN THE COMPLAINT UNDERWENT AN INDEPENDENT PHYSICIAN REVIEW. THE COMPLETED ASSESSMENT IS DOCUMENTED BELOW. ¿THERE IS A CLEAR DESCRIPTION OF THE PROBLEM DURING THE CASE, AND THE IMAGES (8 IN TOTAL) ARE ILLUSTRATIVE. THE EVENT DESCRIBED IS FLATTENING OF THE CATHETER WITH SPIRALING WHICH HAPPENS IF A COMBINATION OF FACTORS IS MET. WHEN THE CG92 IS PULLED BACK WHILE THE TIP IS CORKED (BY A CLOT) AND VACUUM APPLIED, AND IN CASE THERE IS SIMULTANEOUS TRACTION OF THE CATHETER OVER A RIGID AND/OR SHARP LEDGE (IN THIS CASE THE DISTAL EDGE OF THE LONG SHEATH) IN A CURVED ENVIRONMENT, THE FLATTENING MAY HAPPEN. THE RADIOPAQUE BRAIDING OF THE CATHETER WILL ALLOW RECOGNITION MORE EASILY THAN WITH OTHER DEVICES, IN WHICH CASE LOWERING THE LONG SHEATH MAY HELP AVOID THE ISSUE.¿ PHYSICIAN NAME AND DATE REVIEWED: (B)(6) MD, MSC, (B)(6) 2025. UPDATED SECTIONS: B.4, G.3, G.6, H.2, H.6, AND H.11. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AN INITIAL REPORT WAS RECEIVED FROM THE PHYSICIAN REGARDING A CASE PERFORMED WITH A CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122CA / 31747750) HAD RESULTED IN THE DEVICE BEING DAMAGED ON WITHDRAWAL FROM THE PATIENT. THE PROCEDURE WAS A MECHANICAL THROMBECTOMY INVOLVING A PATIENT WHO HAD MISSED HIS WARFARIN FOR THREE (3) DAYS. THE PATIENT SUFFERED A STROKE ON (B)(6) 2025; STROKE ONSET TIME WAS 21:50 HOUR. THE PATIENT WAS PRESENTED TO THE FIRST HOSPITAL WITH AN NIHSS SCORE OF 18 AND AN ASPECTS SCORE OF 9. THE PATIENT WAS THEN TRANSFERRED TO THE SECOND HOSPITAL AT 01:20 HOUR ON (B)(6) 2025, WITH AN NIHSS SCORE OF 25 AND AN ASPECTS SCORE OF 7. THE PATIENT WAS GIVEN THROMBOLYSIS AND THE MECHANICAL THROMBECTOMY WAS UNDERTAKEN UNDER LOCAL ANESTHESIA (DUE TO THE AORTIC VALVE REPLACEMENT). THE PATIENT WAS REPORTED TO HAVE HAD AN OCCLUSION IN THE LEFT PROXIMAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN DESCRIBED THE PATIENT¿S VESSEL AS ¿HAVING A BOVINE TYPE 1 ARCH WITH SOME TORTUOSITY OF THE [INTERNAL CAROTID ARTERY] ICA. AN 8F ARROW LONG SHEATH (TELEFLEX) WAS USED TO GAIN ACCESS TO THE LEFT ICA AND THE TIP OF THIS APPEARS TO BE SITTING ON A BEND / CURVE WITHIN THIS VESSEL. A CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM WAS REPORTED TO HAVE BEEN RELATIVELY EASILY ADVANCED OVER A 0.025¿ GUIDEWIRE (TERUMO) INTO THE PROXIMAL M1 SEGMENT. ASPIRATION WAS PERFORMED VIA THE CEREGLIDE 92 USING A MEDELA SUCTION PUMP (MEDELA) AND SIMULTANEOUSLY VIA THE ARROW SHEATH WITH A VACLOK® VACUUM PRESSURE SYRINGE (MERIT MEDICAL). ONLY A SMALL AMOUNT OF THE CLOT WAS ASPIRATED WITH THE CEREGLIDE 92, AND THE VESSEL WAS NOT FULLY OPEN. THERE WAS SOME VESSEL SPASM NOTED AT THE TIP OF THE ARROW SHEATH. A SECOND PASS WAS PERFORMED WITH THE SAME CEREGLIDE 92 CATHETER. ON THIS PASS, IT WAS ADVANCED MORE DISTAL IN THE M1. ASPIRATION THROUGH THIS CAPTURED SOME MORE CLOT, BUT NOT A SUBSTANTIAL AMOUNT. AN MTICI OF 2B WAS ACHIEVED ON THIS SECOND PASS. WHEN THE CEREGLIDE 92 CATHETER WAS WITHDRAWN / RETRIEVED INTO THE ARROW SHEATH AFTER THE ASPIRATION ATTEMPT, THE PHYSICIAN REPORTED THAT THE DISTAL END OF THE CEREGLIDE 92 APPEARED TO HAVE INTERACTED WITH THE TIP OF THE ARROW SHEATH AND WHEN THE CEREGLIDE 92 WAS REMOVED FROM THE PATIENT¿S ANATOMY, THE DISTAL END APPEARED TO HAVE COLLAPSED / FLATTENED. THE CATHETER WAS COMPLETELY REMOVED, NOTHING OF IT LEFT IN THE PATIENT. THE ARROW SHEATH STAYED IN THE PATIENT, AND A THIRD PASS WAS PERFORMED USING A RED 62 REPERFUSION CATHETER (PENUMBRA) AND A CATCH MINI (CM) STENT RETRIEVER (BALT). IT WAS REPORTED THAT THE CEREGLIDE 92 WAS NOT USED AGAIN AND WAS DISCARDED). ON THIS THIRD PASS, THE LOCATION OF THE OCCLUSION WAS IN THE DISTAL M2 SEGMENT OF THE MCA. THE PHYSICIAN SPECULATED THAT HE THINKS ¿MAYBE ADVANCING THE CEREGLIDE 92 INTO THE DISTAL M1 IN THE PREVIOUS (SECOND PASS) MAY HAVE PUSHED THE CLOT MORE DISTAL.¿ A SUCCESSFUL FOURTH PASS WAS MADE USING THE RED 62 REPERFUSION CATHETER. THE CLOT WAS RETRIEVED AND THE PHYSICIAN SUSPECTED IT WAS A FIBROUS CLOT. THE FOURTH PASS RESULTED IN AN MTICI OF 3. THE PATIENT WAS REPORTED TO HAVE NO NEGATIVE / ADVERSE EFFECTS FROM THE RESULT OF THE CEREGLIDE 92 DEVICE INTERACTION / APPEARANCE. THE PROCEDURE WAS NOT DELAYED BY THE ISSUE WITH THE CEREGLIDE 92 CATHETER. PROCEDURE IMAGES AND PHOTOS OF THE COMPLAINT DEVICES WERE INCLUDED IN THE COMPLAINT. THE PROCEDURE IMAGES WILL UNDERGO INDEPENDENT PHYSICIAN REVIEW, AND THE PHOTOS OF THE DEVICE WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM. ON 30-OCT-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE FIRST TWO PASSES WERE VIA THE ADAPT; THE THIRD PASS WAS A CO-ASPIRATION WITH A STENT RETRIEVER. THERE WAS NEITHER CRACKING NOR FRACTURE SEEN ON THE MATERIAL. THE INFORMATION INDICATED THAT THERE WAS NO CALCIFICATION IN THE TARGET VESSEL; ONLY SOME TORTUOSITY IN THE ICA NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298941 CEREGLIDE CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP CERENOVUS, INC. 31747750 10886704086024

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Life Threatening 0.025¿ GUIDEWIRE (TERUMO)| 8F ARROW LONG SHEATH (TELEFLEX)| CATCH MINI (CM) STENT RETRIEVER (BALT)| MEDELA SUCTION PUMP (MEDELA)| RED 62 REPERFUSION CATHETER (PENUMBRA)| VACLOK® VACUUM PRESSURE SYRINGE (MERIT MEDICAL)