CEREGLIDE

Additional Manufacturer Narrative

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. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT: (31906553) 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.

Description of Event or Problem

THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 132CM CEREGLIDE 71 (CS71132U / 31906553) BECAME KINKED AT SOME POINT DURING A MECHANICAL THROMBECTOMY PROCEDURE. THE ISSUE WAS NOTICED FOLLOWING THE DEVICE BEING SUCCESSFULLY USED TO REMOVE AN OCCLUSION IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), AFTER A TICI SCORE OF 3 WITH REPERFUSION WAS ACHIEVED. THE CEREGLIDE CATHETER WAS REMOVED AFTER BEING USED FOR ASPIRATION AND LATER, A KINK WAS NOTICED. IT WAS NOT ABLE TO BE USED AGAIN. IT WAS THEN REPORTED THAT DIFFERENT CATHETERS, INCLUDING A PROWLER 14 WAS USED TO ACCESS AND TREAT A SEPARATE, MORE DISTAL VESSEL. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 24-JUN-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) CASE, ASPIRATION FIRST. PRE-PROCEDURE TICI SCORE IS NOT AVAILABLE. THE CEREGLIDE WAS USED ONCE, AND IT WAS SUCCESSFUL FOR THE THROMBECTOMY OF THE M1 OCCLUSION. OTHER CATHETERS WERE USED TO ACCESS MORE DISTAL AREA. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT TO THE PATIENT AND NO PROCEDURE DELAY RESULTED FROM THE REPORTED ISSUE.