CEREGLIDE
Report
- Report Number
- 3007628272-2025-00058
- Event Type
- Malfunction
- Date Received
- November 24, 2025
- Date of Event
- November 8, 2025
- Report Date
- December 12, 2025
- Manufacturer
- CERENOVUS, INC.
- Product Code
- NRY
- UDI-DI
- 10886704085393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4) THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 27-NOV-2025. [ADDITIONAL INFORMATION]: ON 27-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A THROMBECTOMY PROCEDURE TARGETING AN ATHEROTHROMBOTIC BRAIN INFARCTION. THE INFORMATION INDICATED THAT THE CEREGLIDE 71 MADE A TOTAL OF ¿2 OR 3 PASSES.¿ THE CEREGLIDE 71 DAMAGE WAS FOUND AFTER RECANALIZATION WAS ACHIEVED. THE CEREGLIDE 71 WAS NOT REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. UPDATED SECTIONS: B.4, G.3, G.6, H.2, 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 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 132CM CEREGLIDE 71 CATHETER WAS RECEIVED. VISUAL INSPECTION PRIOR TO DISINFECTION REVEALED ELONGATION OF THE DISTAL CATHETER, WHICH APPEARED TO BE PROTRUDING FROM THE INNER BRAID. MICROSCOPIC INSPECTION WAS PERFORMED. MAGNIFICATION REVEALED THAT THE PITCH OF THE CATHETER'S BRAIDS HAD WIDENED AND THAT THE COATING ON THE CATHETER SURFACE HAD PEELED OFF IN PLACES. THE WIDENING OF THE BRAID PITCH CONTINUED FROM THE DISTAL END TO APPROXIMATELY 44 CM. NO WIDENING OF THE CATHETER'S BRAID PITCH WAS OBSERVED PROXIMAL TO THE 44 CM POSITION. A DEFORMATION (BULGE) OF THE CATHETER WAS OBSERVED APPROXIMATELY 24 CM FROM THE DISTAL END, AND THE THICKNESS OF THE CATHETER WAS NOT UNIFORM FROM THE DEFORMED AREA TO THE PROXIMAL SIDE. A KINK WAS OBSERVED IN THE CATHETER APPROXIMATELY 57 CM FROM THE DISTAL END. FUNCTIONAL TEST CONFIRMED THE CATHETER HAD A HYDROPHILIC COATING. THE DISTAL INNER DIAMETER AND PROXIMAL OUTER DIAMETER OF THE CATHETER WERE WITHIN SPECIFICATIONS, BUT THE DISTAL OUTER DIAMETER WAS OUTSIDE THE SPECIFICATIONS. THE TOTAL LENGTH OF THE CATHETER WAS APPROXIMATELY 149.5CM. WHEN WATER WAS PASSED THROUGH THE CATHETER USING A LAB SAMPLE SYRINGE, A LEAK WAS DETECTED APPROXIMATELY 17.5CM FROM THE DISTAL END OF THE CATHETER. REGARDING THE REPORTED ISSUE OF CEREGLIDE 71 BREAKING AND FORMING HOLES, WE HAVE CONFIRMED THAT THE DISTAL CATHETER OF THE RETURNED PRODUCT HAD ELONGATED AND FORMED HOLES. IT IS POSSIBLE THAT THE CATHETER STRETCHED DURING USE DURING SURGERY, CAUSING THE COATING TO BREAK DOWN AND RESULTING IN A HOLE. HOWEVER, DUE TO LIMITED INFORMATION ABOUT THE CONDITIONS UNDER WHICH THE CATHETER WAS USED, WE WERE UNABLE TO IDENTIFY THE DIRECT CAUSE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31567165) 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. ALTHOUGH NO CONCLUSIONS HAVE BEEN REACHED AS TO THE CAUSE OF THE REPORTED EVENTS, THE INSTRUCTION FOR USE (IFU) INCLUDES THE FOLLOWING PRECAUTIONS: -DO NOT ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE DEVICE AGAINST RESISTANCE COULD DAMAGE THE DEVICE OR CAUSE PATIENT INJURY. -USE CAUTION WHEN MANIPULATING, ADVANCING AND/OR WITHDRAWING DEVICES THROUGH NEEDLES, METAL CANNULAS, STENTS, OR OTHER DEVICES WITH SHARP EDGES, OR THROUGH TORTUOUS OR CALCIFIED BLOOD VESSELS. 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). 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 E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. 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. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31567165) 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. 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 THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 01-DEC-2025. 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 MECHANICAL THROMBECTOMY PROCEDURE TO TREAT A CEREBRAL INFRACTION, THE DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). THE PROCEDURE WAS PERFORMED VIA TRANS RADIAL ARTERY. THE TARGET LESION WAS AN ATHEROTHROMBOTIC BRAIN INFRACTION. A BRANCHOR¿ BALLOON CATHETER (ASAHI INTECC) AND A TIGERTRIEVER¿ STENT RETRIEVER (RAPID MEDICAL) WERE CONCOMITANTLY USED WITH THE 132CM CEREGLIDE 71 CATHETER (NIC71132C / 31567165). THE TIGERTRIEVER¿ STENT RETRIEVER WAS USED WITH AN ADJUSTABLE FEATURE. IT WAS REPORTED THAT DILATION WAS ATTEMPTED FOR THE ATHEROTHROMBOTIC BRAIN INFARCTION, AND ¿ON THE SECOND OR THIRD PASS, THE CEREGLIDE 71 CATHETER SUSTAINED DAMAGE AND A HOLE WAS FOUND.¿ IT WAS THEN REPORTED THAT ¿RECANALIZATION WAS ACHIEVED AND, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE PHYSICIAN REPORTEDLY REQUESTED THAT THE COMPATIBILITY BETWEEN THE CEREGLIDE 71 CATHETER AND THE TIGERTRIEVER¿ STENT RETRIEVER, ¿AND WHETHER THERE HAVE BEEN ANY OTHER SIMILAR EVENTS.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194072 | CEREGLIDE | CATHETER, THROMBUS RETRIEVER | NRY | CERENOVUS, INC. | 31567165 | 10886704085393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | BRANCHOR¿ BALLOON CATHETER (ASAHI INTECC)| TIGERTRIEVER¿ STENT RETRIEVER (RAPID MEDICAL) |