BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVOY

    MDR report key: 24388305 · Received February 19, 2026

    Report

    Report Number
    3007628272-2026-00013
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    January 31, 2026
    Report Date
    March 13, 2026
    Manufacturer
    CERENOVUS, INC.
    Product Code
    DQY
    UDI-DI
    10886704075035
    PMA / PMN Number
    K000715
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4) INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION H3 - 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2, AND H11. SECTION B5: ADDITIONAL EVENT INFORMATION INDICATED THAT THE TARGET VESSEL BEING TREATED WAS THE RIGHT M1 SEGMENT OF THE INTERNAL CAROTID ARTERY (RT ICA M1 SEGMENT). THE EXACT LOCATION OF THE FRAGMENT AT THE TIME OF SEPARATION IS PENDING CONFIRMATION FROM THE CUSTOMER; THE PROVISIONAL LOCATION IS THE RIGHT FEMORAL ARTERY. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4) UPDATED SECTIONS ON THIS MEDWATCH: B4, G3, G6, H2, H3, H6 AND H11. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE ENVOY, 7F, 90 CM, SIMMONS 2 WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE CATHETER PRESENTS MULTIPLE SECTIONS OF SEVERE MECHANICAL DAMAGE. MICROSCOPIC INSPECTION REVEALED FURTHER DAMAGE INCLUDING ABRASION, TEARING, AND DISPLACEMENT OF THE OUTER SHAFT JACKET. 6 CM OF INTERNAL BRAIDED WIRE IS EXPOSED AND VISIBLY WORN. THE DAMAGED AREAS INDICATE PROLONGED MECHANICAL STRESS, BENDING AND FRICTION. THE DISTAL 14CM OF THE REMAINING CATHETER SHOWED SEVERE STRETCHING TO THE POINT OF COILING EXPOSING THE INTERNAL BRAIDED WIRE. THE SEVERE DAMAGE PREVENTED PROPER DIMENSIONAL INSPECTION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE REPORTED ISSUE OF A SEPARATED CATHETER HAS BEEN CONFIRMED. THE MULTIPLE AREAS OF DAMAGE OBSERVED ON THE DEVICE ARE CONSISTENT WITH POTENTIAL INTERACTION WITH ANCILLARY TOOLS, AS OUTLINED IN THE RISK DOCUMENTATION, WHICH IDENTIFIES CATHETER DAMAGE AND SEPARATION AS POSSIBLE OUTCOMES DURING THE REMOVAL OF ANCILLARY DEVICES. ADDITIONALLY, CLINICAL AND PROCEDURAL FACTORS, PARTICULARLY THE SEVERE VESSEL TORTUOSITY NOTED IN THE CASE, MAY HAVE INCREASED FRICTION AND MECHANICAL LOADING ON THE CATHETER DURING WITHDRAWAL, CONTRIBUTING TO BOTH THE REPORTED DIFFICULTY RETRIEVING THE DEVICE FROM THE VESSEL AND THE SUBSEQUENT IN-PATIENT SEPARATION. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. AS PART OF THE J&J MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO INTERNAL ACTION ACTIVITY IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING PRECAUTIONS: IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE FOR THE RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER. TORQUING THE CATHETER EXCESSIVELY WHILE KINKED MAY CAUSE DAMAGE WHICH COULD RESULT IN POSSIBLE SEPARATION ALONG THE CATHETER SHAFT. SHOULD THE GUIDING CATHETER SHAFT BECOME SEVERELY KINKED, WITHDRAW THE ENTIRE SYSTEM (GUIDING CATHETER, GUIDEWIRE, AND CATHETER SHEATH INTRODUCER). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, VIA EMAIL, THAT AN ENVOY, 7F, 90 CM, SIMMONS 2 (77825290/ 31708615) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED ENVOY CATHETER- WITHDRAWAL DIFFICULTY FROM VESSEL AND SEPARATION WHILE IN PATIENT. THE PHYSICIAN USED A ZOOM55 REPERFUSION CATHETER (IMPERATIVE CARE, INC.) INSIDE THE ENVOY AND HAD AN 8FR SHEATH (UNSPECIFIED BRAND) FOR FEMORAL ACCESS. DUE TO SEVERE VESSEL TORTUOSITY, THE USER WAS ¿UNABLE TO SELECT TO ADVANCE.¿ THE PHYSICIAN DECIDED TO WITHDRAW THE ENVOY CATHETER BUT EXPERIENCED DIFFICULTY/RESISTANCE. ¿CATHETER DISTALLY BROKE OFF AND REMAINED INSIDE PATIENT.¿ THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿AFTER TRYING TO SELECT IN A TYPE III ARCH WITH VERY TORTUOSITY VESSELS, UNABLE TO SELECT TO ADVANCE. WHEN, PHYSICIAN DECIDED TO PULL THE 7FR ENVOY CATHETER SIM 2 BY 90CM LENGTH, IT WAS HARD TO PULL CATHETER. CATHETER DISTALLY BROKE OFF AND REMAINED INSIDE PATIENT. PHYSICIAN HAD USED A ZOOM 55 INSIDE THE ENVOY AND HAD AN 8FR SHEATH FOR FEMORAL ACCESS.¿ ON 14-FEB-2026, ADDITIONAL EVENT INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE. SUMMARY: PER THE INFORMATION PROVIDED, IT WAS CONFIRMED THAT THE CATHETER STRETCHED, THEN SEPARATED INTO TWO PIECES. THE DISTAL END OF THE CATHETER REMAINED IN THE PATIENT; FURTHER INFORMATION REGARDING THE EXACT SIZE AND LOCATION OF THE REMAINING FRAGMENT IS CURRENTLY PENDING. THE TREATING PHYSICIAN STATED, ¿DUE TO TORTUOSITY, UNABLE TO PERFORM THROMBECTOMY ON THE PATIENT, THE REMAINING PIECE STAYED INSIDE PATIENT AS FAMILY REQUESTED NO FURTHER INTERVENTION.¿ NO FURTHER INTERVENTION IS PLANNED. THE TARGET VESSEL BEING TREATED WAS THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS NO EVIDENCE OF VESSEL INJURY DURING ATTEMPTS TO WITHDRAW THE CATHETER OR AFTER THE CATHETER SEPARATED. THERE WAS NO EVIDENCE OF VASOSPASM DURING THE EVENT. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO THE ALLEGED PRODUCT ISSUE, INCLUDING PROLONGED HOSPITALIZATION. FURTHER INFORMATION REGARDING WHETHER THE RETAINED CATHETER FRAGMENT RESTRICTED BLOOD FLOW OR CAUSED VESSEL COMPROMISE IS CURRENTLY PENDING CUSTOMER RESPONSE. THE CATHETER IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490631 ENVOY PERCUTANEOUS CATHETER DQY CERENOVUS, INC. 31708615 10886704075035

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Unknown Life Threatening 8F ACCESS SHEATH (UNSPECIFIED BRAND).| ZOOM¿ ASPIRATION CATHETER (IMPERATIVE CARE).