BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY

    MDR report key: 23554557 · Received November 14, 2025

    Report

    Report Number
    3007628272-2025-00060
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 8, 2025
    Manufacturer
    CERENOVUS, INC.
    Product Code
    DQY
    UDI-DI
    10886704031703
    PMA / PMN Number
    K000715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4) UPDATED SECTIONS ON THIS MEDWATCH: B4, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: THE DISTRIBUTOR RECEIVED 3 BOXES THAT APPEARED TO HAVE BEEN OPENED, ENVOY 6F, XB MPC 100CM (67025600B / 31675240). A PERSON FROM THE QUALITY TEAM WENT TO INSPECT THE PRODUCTS INSIDE. THE PRODUCTS AND THEIR INTERNAL PACKAGING DO NOT APPEAR TO BE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2025 STATING THAT THE PRODUCTS INSIDE THE BOXES WERE INTACT, AND CONFIRMING THERE WAS DAMAGE TO THE SHIPPING BOX, THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES, AS IF SOMEONE HAD OPENED THE CARTON TO SEE WHAT WAS INSIDE. UNFORTUNATELY, THEIR LOGISTICS DEPARTMENT DISCARDED THE SHIPPING CARTON BEFORE TAKING PICTURES OF THE OPEN BOXES. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PRODUCT INSIDE THE BOXES WERE INTACT. THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES. TWO PHOTOS WERE ATTACHED TO THE COMPLAINT FILE. IN SUCH PHOTOS THE THREE BOXES CAN BE SEEN FROM THE FRONT ANGLE, PRESENTING SLIGHT BENT DAMAGE AT THE TOP LID, AND ON THE SECOND PHOTO FROM A TOP VIEW, THE THREE BOXES SEALS CAN BE SEEN TO BE CUT APPARENTLY WITH A NON-SHARP OBJECT. NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. THE OUTER PACKAGING OF AN ENVOY 6F, XB MPC 100CM WAS RECEIVED. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND AT THE MIDDLE OF THE OUTER PACKAGING, A HORIZONTAL TEAR WITH DENTED EDGES CAN BE SEEN ON THE SIDE PANEL. NO ADDITIONAL DAMAGES ARE SEEN. THE INNER POUCH AN ENVOY CATHETER WERE UNDAMAGED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE DAMAGED BOX IS CONFIRMED. THIS ISSUE COULD BE RELATED TO TRANSPORTATION, AS IT WAS CONFIRMED THAT THE SHIPPING BOX WAS DAMAGED. 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 ISSUE, NO INTERNAL ACTION ACTIVITY IS REQUIRED AT THIS TIME. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATION: DO NOT USE OPEN OR DAMAGED PACKAGES. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). TWO PHOTOS WERE ATTACHED TO THE COMPLAINT FILE. IN SUCH PHOTOS THE THREE BOXES CAN BE SEEN FROM THE FRONT ANGLE, PRESENTING SLIGHT BENT DAMAGE AT THE TOP LID, AND ON THE SECOND PHOTO FROM A TOP VIEW, THE THREE BOXES¿ SEALS CAN BE SEEN TO BE CUT APPARENTLY WITH A NON-SHARP OBJECT. NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31675240 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE ISSUE REGARDING THE BOXES BEING DAMAGED AND TORN WAS CONFIRMED BASED ON THE AVAILABLE PHOTO EVIDENCE. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THEREFORE, NO INTERNAL ACTIVITY IS REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THE PRODUCTS HAVE RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 0

    THE DISTRIBUTOR RECEIVED 3 BOXES THAT APPEARED TO HAVE BEEN OPENED, ENVOY 6F, XB MPC 100CM (67025600B / 31675240). A PERSON FROM THE QUALITY TEAM WENT TO INSPECT THE PRODUCTS INSIDE. THE PRODUCTS AND THEIR INTERNAL PACKAGING DO NOT APPEAR TO BE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2025 STATING THAT THE PRODUCTS INSIDE THE BOXES WERE INTACT, AND CONFIRMING THERE WAS DAMAGE TO THE SHIPPING BOX, THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES, AS IF SOMEONE HAD OPENED THE CARTON TO SEE WHAT WAS INSIDE. UNFORTUNATELY, THEIR LOGISTICS DEPARTMENT DISCARDED THE SHIPPING CARTON BEFORE TAKING PICTURES OF THE OPEN BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788789 ENVOY PERCUTANEOUS CATHETER DQY CERENOVUS, INC. 31675240 10886704031703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown