BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY

    MDR report key: 23416791 · Received October 29, 2025

    Report

    Report Number
    3007628272-2025-00052
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 17, 2025
    Manufacturer
    CERENOVUS, INC.
    Product Code
    DQY
    PMA / PMN Number
    K093184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. 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 (31064488) 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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.

    Additional Manufacturer Narrative · 0

    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 ENVOY® GUIDING CATHETER, 6F, 100 CM WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. MULTIPLE KINKS WERE FOUND ALONG THE ENTIRE LENGTH OF THE CATHETER. THE ISSUE REGARDING RESISTANCE WHEN ATTEMPTING TO ADVANCE THE MICROCATHETER CANNOT BE EVALUATED THROUGH FUNCTIONAL TESTING. THE MULTIPLE KINKS OBSERVED DURING THE VISUAL INSPECTION PREVENT A FUNCTIONAL TEST FROM BEING PERFORMED. THIS DAMAGE IS SUSPECTED TO HAVE APPEARED DURING THE POST-OPERATIONAL HANDLING OF THE DEVICE SINCE NO DAMAGES WERE REPORTED TO BE OBSERVED ON THE CATHETER DURING THE ISSUE. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31064488) 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. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: ¿ DO NOT USE A CATHETER THAT HAS BEEN DAMAGED IN ANY WAY. IF DAMAGE IS DETECTED, REPLACE IT WITH ANOTHER ENVOY GUIDING CATHETER THAT IS NOT DAMAGED. 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.

    Additional Manufacturer Narrative · 0

    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 10-NOV-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.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) ENCOUNTERED SOME RESISTANCE DURING THE PROCESS OF IT BEING DELIVERED TO THE ENVOY® GUIDING CATHETER, 6F, 100 CM (67025800 / 31064488), BUT THE MICROCATHETER STILL PASSED THROUGH THE GUIDE CATHETER AND WAS DELIVERED TO THE TARGET SITE. THE 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401612 / 7773921) WAS IMPEDED IN THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE GUIDE CATHETER, THE MICROCATHETER, AND THE STENT FROM THE PATIENT. THE PHYSICIAN REPLACED THE GUIDE CATHETER AND THE STENT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. ON 19-OCT-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE MIDDLE CEREBRAL ARTERY (MCA). A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE HAD BEEN RESISTANCE DURING THE ADVANCEMENT OF THE STENT AT THE PROXIMAL SECTION OF THE MICROCATHETER. WHEN THE STENT WAS REMOVED, IT WAS STILL ON THE DELIVERY WIRE. THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGED. THE INFORMATION INDICATED THAT THE REPLACEMENT GUIDE CATHETER WAS ANOTHER ENVOY® GUIDING CATHETER, 6F, 100 CM (67025800) AND THE REPLACEMENT STENT WAS ANOTHER 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (ENCR401612). PER THE INFORMATION, THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599149 ENVOY PERCUTANEOUS CATHETER DQY CERENOVUS, INC. 31064488

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENTERPRISE2 4MMX16MM.| PROWLER SELECT PLUS 150/5CM.