EMBOGUARD
Report
- Report Number
- 3011370111-2025-00111
- Event Type
- Malfunction
- Date Received
- October 20, 2025
- Date of Event
- October 5, 2025
- Report Date
- October 28, 2025
- Manufacturer
- NEURAVI LTD.
- Product Code
- QJP
- UDI-DI
- 10886704082743
- PMA / PMN Number
- K212340
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER REFERENCE # (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2, H6 AND H11. COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF THE COMMON CAROTID ARTERY TO TREAT INTERNAL CAROTID ARTERY OCCLUSION. AFTER THE PREPARATION OF AN EMBOGUARD 87, 95 CM BALLOON CATHETER (BG8795U, 8970678) WAS COMPLETED, ATTEMPTED APPROACH FROM THE AORTIC ARCH TO THE BRACHIOCEPHALIC ARTERY AND THE RIGHT COMMON CAROTID ARTERY. AN INNER CATHETER (SIMMONS) WAS INSERTED INTO THE EMBOGUARD, WHICH FOLLOWED AND WAS PLACED IN THE RIGHT COMMON CAROTID ARTERY. WHEN THE INNER CATHETER WAS REMOVED, THE EMBOGUARD GOT KINKED. THE EMBOGUARD WAS REMOVED FROM THE PATIENT¿S BODY, AND ANOTHER COMPANY¿S BALLOON GUIDING CATHETER (FLOWGATE) WAS INSERTED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS EXTENDED, BUT THERE WAS NO SIGNIFICANT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE UNKNOWN. AORTA ARCH TYPE, PUNCTURE SITE, LESION, KINKED TIMING, AND LOCATION OF CATHETER TIP WERE UNKNOWN. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR SUE (IFU). ADDITIONAL EVENT INFORMATION RECEIVED ON 14-OCT-2025 INDICATED THAT THE DEVICE DEFICIENCY DID NOT RESULT IN PATIENT HARM. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 28-OCT-2025 INDICATING THAT THE DEVICE WAS NOT ADVANCED OR WITHDRAWN AGAINST RESISTANCE. THERE IS NO ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE REPORTED FAILURE COULD NOT BE EVALUATED. A DEVICE HISTORY REVIEW (DHR) ASSOCIATED WITH LOT 8970678 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY REVIEW EVALUATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THERE ARE CIRCUMSTANCES OF THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE INSTRUCTIONS FOR USE (IFU) OF THE EMBOGUARD DEVICES CAUTIONS USERS AGAINST ADVANCING OR WITHDRAWING THE CATHETER OR DILATOR AGAINST RESISTANCE WITHOUT CAREFUL ASSESSMENT OF THE CAUSE OF RESISTANCE USING FLUOROSCOPY. IF CAUSE CANNOT BE DETERMINED, WITHDRAW THE CATHETER/DILATOR WHILE EXERCISING CAUTION. MOVEMENT AGAINST RESISTANCE MAY RESULT IN DAMAGE TO VESSEL OR CATHETER/DILATOR, E.G. KINKING, OR CAUSE PATIENT INJURY. ADDITIONALLY, IF THE EMBOGUARD CATHETER BECOMES SEVERELY KINKED, USERS ARE INSTRUCTED TO WITHDRAW THE ENTIRE SYSTEM, (I.E. EMBOGUARD CATHETER, INTERMEDIATE CATHETER, GUIDEWIRE, ETC.). USE OF A DAMAGED DEVICE MAY RESULT IN VESSEL INJURY. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
MANUFACTURER REF#: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. 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.
A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF THE COMMON CAROTID ARTERY TO TREAT INTERNAL CAROTID ARTERY OCCLUSION. AFTER THE PREPARATION OF AN EMBOGUARD 87, 95 CM BALLOON CATHETER (BG8795U, 8970678) WAS COMPLETED, ATTEMPTED APPROACH FROM THE AORTIC ARCH TO THE BRACHIOCEPHALIC ARTERY AND THE RIGHT COMMON CAROTID ARTERY. AN INNER CATHETER (SIMMONS) WAS INSERTED INTO THE EMBOGUARD, WHICH FOLLOWED AND WAS PLACED IN THE RIGHT COMMON CAROTID ARTERY. WHEN THE INNER CATHETER WAS REMOVED, THE EMBOGUARD GOT KINKED. THE EMBOGUARD WAS REMOVED FROM THE PATIENT¿S BODY, AND ANOTHER COMPANY¿S BALLOON GUIDING CATHETER (FLOWGATE) WAS INSERTED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS EXTENDED, BUT THERE WAS NO SIGNIFICANT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE UNKNOWN. AORTA ARCH TYPE, PUNCTURE SITE, LESION, KINKED TIMING, AND LOCATION OF CATHETER TIP WERE UNKNOWN. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR SUE (IFU). ADDITIONAL EVENT INFORMATION RECEIVED ON 14-OCT-2025 INDICTED THAT THE DEVICE DEFICIENCY DID NOT RESULT IN PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2285761 | EMBOGUARD | CATHETER, PERCUTANEOUS, NEUROVASCULATURE | QJP | NEURAVI LTD. | 8970678 | 10886704082743 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SIMMONS CATHETER (UNSPECIFIED BRAND). |