CEREGLIDE
Report
- Report Number
- 3007628272-2025-00065
- Event Type
- Injury
- Date Received
- December 18, 2025
- Date of Event
- December 4, 2025
- Report Date
- January 30, 2026
- Manufacturer
- CERENOVUS, INC.
- Product Code
- NRY
- UDI-DI
- 10886704086550
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4) INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.2B: PROCODE IS NRY/QJP. SECTION H.3: THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. THE PRODUCT ANALYSIS TEAM REVIEWED THE VIDEO THAT WAS ADDED TO THE COMPLAINT. THE REVIEW IS DOCUMENTED BELOW. [VIDEO REVIEW]: IN THE VIDEO, THE DISTAL END OF THE CEREGLIDE 42 CATHETER WAS IN THE PROCESS OF BEING INSERTED INTO THE LUER HUB OF A CEREGLIDE 57 CATHETER; HOWEVER, AFTER MULTIPLE ATTEMPTS TO INSERT THE CEREGLIDE 42, THE CEREGLIDE 42 CATHETER COULD NOT BE ADVANCED THROUGH THE CEREGLIDE 57 CATHETER. THE LOCATION OF THE KINK WAS NOT SHOWN IN THE VIDEO. THE REPORTED ISSUE RELATED TO THE CEREGLIDE 42 CATHETER WAS CONFIRMED. HOWEVER, THE ROOT CAUSE OF SUCH OBSTRUCTED CONDITION CANNOT BE DETERMINED WITH THE VIDEO AS THAT WOULD REQUIRE A FUNCTIONAL EVALUATION OF THE DEVICE. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE VIDEO PROVIDED. AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31766662) 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. THROMBOEMBOLISM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE CEREGLIDE57 CATHETER AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE ARE CLINICAL AND PROCEDURAL FACTORS INCLUDING CLOT BURDEN, VESSEL CHARACTERISTICS, AND MECHANICAL MANIPULATION OF DEVICES THAT MAY HAVE CONTRIBUTED TO THE EVENT RATHER THAN A DEVICE DESIGN OR MANUFACTURING ISSUE. IN THIS CASE, THERE WERE NO REPORTS OF PATIENT INJURY; HOWEVER, THE EVENT REQUIRED AN ADDITIONAL PASS TO RETRIEVE THE CLOT. THEREFORE, THIS EVENT MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ ADDITIONALLY, IT WAS REPORTED THAT THE USER EXPERIENCED CATHETER OBSTRUCTION-IN PATIENT WITH NO LOSS OF CEREBRAL TARGET POSITION AND DAMAGED/DEFORMED -IN PATIENT DURING THROMBECTOMY. CATHETER DEFORMATION/DAMAGE DURING THROMBECTOMY PRESENTS THE POTENTIAL FOR PATIENT HARM, AS THIS MAY INHIBIT THE ASPIRATION FUNCTION, REQUIRING THE DEVICE TO BE REPLACED. THIS IS EXPECTED TO OCCUR AT A CRITICAL PROCEDURAL STEP WHERE HIGH RISK TO THE PATIENT MAY BE PRESENT, WITH AN INCREASED RISK OF WORSENING ISCHEMIA. HOWEVER, OBSTRUCTION OF A DEVICE IS A KNOWN EVENT. REMOVAL AND EXCHANGE OF DEVICES IS COMMON ROUTINE PRACTICE IN ENDOVASCULAR PROCEDURES. IN THIS CASE, THE EXCHANGE OF THE DEVICE IS DONE WITHOUT LOSS OF INTRACRANIAL TARGET POSITION. THIS IS A COMMON PRACTICE DURING PROCEDURES AND IS RECOMMENDED IN PRODUCT IFU¿S. SINCE THE VAST MAJORITY OF DIAGNOSTIC AND INTERVENTIONAL ANGIOGRAPHIC PROCEDURES UTILIZE MULTIPLE DEVICE EXCHANGES, AN INCREASED POTENTIAL FOR PATIENT INJURY IS REMOTE. SINCE THE CATHETER OBSTRUCTION OCCURRED AFTER THE THROMBOEMBOLISM EVENT, THERE IS NO EVIDENCE TO SUGGEST THIS MALFUNCTION CONTRIBUTED TO THE PATIENT EVENT. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 137 CM CEREGLIDE 57 CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. NO APPEARANCE OF DAMAGE WAS OBSERVED. AN UNSUCCESSFUL ATTEMPT WAS MADE TO INSERT THE 160CM CEREGLIDE 42 CATHETER INTO THE 137 CM CEREGLIDE 57 CATHETER. THE SAME REPORTED RESTRICTION REPORTED IN THE COMPLAINT WAS EXPERIENCED. THE CEREGLIDE 42 CATHETER OVALIZED TIP CAUSED THE RESTRICTION WHEN IT WAS BEING ADVANCED IN THE HUB OF THE CEREGLIDE 57 CATHETER. A LAB SAMPLE CEREGLIDE 42 CATHETER WAS INTRODUCED THROUGH THE INNER LUMEN OF THE RETURNED DEVICE, AND IT WAS ABLE TO BE ADVANCED THROUGH. THE LAB SAMPLE CEREGLIDE 42 WAS ABLE TO PASS THROUGH THE RETURNED CEREGLIDE 57 CATHETER WITHOUT RESISTANCE AND NO DAMAGES WERE NOTED DURING DEVICE INSPECTION. THE ISSUE REPORTED IN THE COMPLAINT CANNOT BE CONFIRMED WITH THE EVIDENCE AVAILABLE. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULT FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31766662) 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. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALL THE DEVICES ARE 100% INSPECTED FOR DEFECTS. IT SHOULD BE NOTED THAT MULTIPLE FACTORS COULD CAUSE PRODUCT FAILURE. THE INSTRUCTION FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATION: DO NOT ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, 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.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 12-JAN-2026. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, 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.
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE (AIS) TARGETING AN OCCLUSION IN THE A2 SEGMENT OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA), A CEREBASE, A 137 CM CEREGLIDE 57 CATHETER (NIC57137U / 31766662), AN ARISTOTLE® 18 GUIDEWIRE (SCIENTIA VASCULAR) WERE USED TO NAVIGATE TO THE CLOT FACE. AFTER ONE (1) PASS, A MAJORITY OF THE CLOT WAS REMOVED BUT SOME CLOT HAD MIGRATED DISTAL INTO THE A3 SEGMENT. THE CEREGLIDE 57 CATHETER WAS THEN TRACKED UP AGAIN, BUT IT WAS UNABLE TO REACH THE DISTAL CLOT AND A 160CM CEREGLIDE 42 CATHETER (NIC42160U / 31766628) WAS USED TO REACH THE CLOT. IT WAS REPORTED THAT DURING THE ATTEMPT TO INSIDER THE CEREGLIDE 42 INTO THE CEREGLIDE 57, THE CEREGLIDE 42 WAS UNABLE TO TRAVERSE PAST THE HUB OF THE CEREGLIDE 57. IT WAS NOTED THAT THERE WAS A SMALL KINK IN THE CEREGLIDE 57 CATHETER, BUT IT WAS MUCH MORE DISTAL TO THE HUB OF THE DEVICE, AND IT WAS NOT THE CAUSE OF THE CEREGLIDE 42 CATHETER NOT FITTING INTO THE CEREGLIDE 57 CATHETER. AFTER MANY UNSUCCESSFUL ATTEMPTS OF TRYING TO PUT THE CEREGLIDE 42 INTO THE CEREGLIDE 57, THE PHYSICIAN PULLED THE CEREGLIDE 57 OUT AND TRAVERSED UP TO THE CLOT USING ONLY THE CEREGLIDE 42 AND A WIRE. THE CLOT WAS SUCCESSFULLY ASPIRATED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT HARM AND WITHOUT ANY CLINICALLY SIGNIFICANT DELAY. A VIDEO WAS ADDED TO THE COMPLAINT ON 08-DEC-2025. THE VIDEO WILL UNDERGO REVIEW BY THE PRODUCT ANALYSIS TEAM. ON 10-DEC-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE CLOT WAS 50/50 RED BLOOD CELL (RBC) AND FIBRIN. THE INFORMATION ALSO INDICATED THAT VESSEL TORTUOSITY HAD NO EFFECT ON COMPATIBILITY ¿SINCE THE 42 WOULD NOT FIT INSIDE THE MOST PROXIMAL PORTION OF THE 57 CATHETERS (FIRST PART OF THE CATHETER LEAVING THE HUB).¿ THE CEREGLIDE 57 CATHETER MADE A TOTAL OF ONE (1) PASS AND THE CEREGLIDE 42 CATHETER ALSO MADE ONE (1) PASS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2241938 | CEREGLIDE | CATHETER, THROMBUS RETRIEVER | NRY | CERENOVUS, INC. | 31766662 | 10886704086550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | 160CM CEREGLIDE 42 CATHETER| ARISTOTLE 18¿ GUIDEWIRE (SCIENTIA VASCULAR)| UNKCEREBASE |