BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPOWER

    MDR report key: 22730118 · Received August 6, 2025

    Report

    Report Number
    3007628272-2025-00037
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Report Date
    March 17, 2026
    Manufacturer
    CERENOVUS, INC.
    Product Code
    HCG
    UDI-DI
    878528000044
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION B.3: DATE OF EVENT: THE DATE OF THE EVENT WAS NOT REPORTED / KNOWN. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. 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 (30978852) 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 (AND/OR PART 4, AS APPLICABLE). 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 JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, JOHNSON & JOHNSON MEDTECH, 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: PC-(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 ENPOWER CONTROL CABLE WAS RECEIVED CONTAINED IN THE ORIGINAL PACKAGING BOX. VISUAL INSPECTION WAS PERFORMED. NO APPEARANCE OF DAMAGE WAS FOUND ON THE OUTER BOX. UPON REMOVING THE INNER POUCH, IT WAS NOTED THAT THE SEAL WAS ONLY PARTIALLY CLOSED. IT APPEARS TO BE UNEVEN ON THIS SIDE OF THE POUCH. THE REMAINING POUCH PERIMETER IS COMPLETELY SEALED AS EXPECTED. THE REPORTED ISSUE IN THE COMPLAINT REGARDING AN OPEN PRODUCT PACKAGE WAS CONFIRMED DURING THE INSPECTION. HOWEVER, A ROOT CAUSE FOR THE CONDITION CANNOT BE CONCLUSIVELY DETERMINED SINCE A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT ALL INSPECTION POINTS RELEVANT TO THE POUCH CHEVRON SEAL WERE FOUND TO BE WITHIN ACCEPTABLE PARAMETERS AS PER WORK INSTRUCTION. THE POUCHING PROCEDURE DOES INCLUDE A 100% INSPECTION/VERIFICATION FOR SEAL, LOOSE PARTICLES / FIBERS, AND HOLES OR DAMAGE TO THE POUCH. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30978852) 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. A POTENTIAL PRODUCT ISSUE RELATED TO THE SUPPLIER MANUFACTURING AND / OR INSPECTION PROCESS WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED, HOWEVER IT CANNOT BE CONCLUSIVELY CONFIRMED. THIS CONDITION HAS BEEN NOTIFIED TO TYVEK POUCH SUPPLIER FOR INVESTIGATION AND IS BEING ADDRESSED THROUGH THEIR QUALITY SYSTEM. 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 INCLUDE THE RESULT OF THE INVESTIGATION FROM THE SUPPLIER OF THE POUCH. THE POUCH SAMPLE WAS FORWARDED TO THE TYVEK POUCH SUPPLIER. THE SAMPLE REVIEW FOUND THE CHEVRON SEAL MOSTLY PEELED WITH VARYING AREAS OF SEPARATION AND CLEAR EVIDENCE OF SEAL CREEP AND WHITE TRANSFER AROUND THE POUCH PERIMETER. THE TEAM BELIEVES THE OBSERVED CREEP LIKELY RESULTED FROM TRAPPED AIR EXPANDING AFTER SEALING¿POSSIBLY DURING TRANSIT OR ALTITUDE CHANGES¿RATHER THAN FROM THE MOUNTING CARD FIT OR HANDLING AND NOTES LOWER PEEL STRENGTH IN THE MACHINE DIRECTION COULD MAKE THE CHEVRON SEAL MORE PRONE TO THIS BEHAVIOR. MINOR ABRASION AND SLIGHT WEB SEPARATION AT THE OPEN END APPEAR RELATED TO LOADING AND OPENING, NOT THE BREACH. BECAUSE ONLY ONE POUCH SHOWED THE ISSUE AND THE CUSTOMER¿S IN-PROCESS INSPECTION DID NOT DETECT IT, THESE FINDINGS CANNOT BE COMPLETELY CONCLUSIVE. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, 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 22-SEP-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

    IT WAS REPORTED THAT PRIOR TO THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE DEVICE PACKAGING FOR THE ENPOWER CONTROL CABLE ((B)(6) / 30978852) WAS OPEN. THERE WAS NO PATIENT IMPACT. ON 04-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, IT WAS THE INNER PACKAGING THAT WAS OPENED. THE STERILE SEAL WAS REPORTEDLY BREACHED, THUS COMPROMISING THE STERILITY OF THE DEVICE. THERE WAS NO DAMAGE TO THE PACKAGING ELEMENTS. THE ORIGINAL PACKAGING WILL BE RETURNED. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 04-AUG-2025, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555571 ENPOWER NEUROVASCULAR EMBOLIZATION DEVICE HCG CERENOVUS, INC. 30978852 878528000044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown