BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPINPLUS NAV 6X16MM 3 GUIDE

    MDR report key: 24324825 · Received February 12, 2026

    Report

    Report Number
    3003418325-2026-00004
    Event Type
    Death
    Date Received
    February 12, 2026
    Date of Event
    January 13, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PGW
    UDI-DI
    10705031241015
    PMA / PMN Number
    K171687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H11. CORRECTED FIELD: B5. IT WAS REPORTED THAT IN-OFFICE BALLOON SINUPLASTY USING RELIEVA SPINPLUS NAV BALLOON WAS PERFORMED ON A PATIENT, TREATING BILATERAL SINUSES. IT WAS REPORTED THAT THE DEVICE WAS CONNECTED TO IRRIGATION AND/OR SUCTION; HOWEVER, IT WAS NOT SPECIFIED WHETHER IRRIGATION, SUCTION, OR BOTH WERE USED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE SPINPLUS NAVIGATED BALLOON (B)(6) WAS NOT RETURNED AND LOT NUMBER INFORMATION WAS NOT PROVIDED; THEREFORE, DEVICE ANALYSIS COULD NOT BE PERFORMED AND DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A MEDICAL ASSESSMENT WAS PERFORMED TO EVALUATE THE POSSIBLE RELATION BETWEEN THE REPORTED EVENT AND PRODUCT USE. THE ASSESSMENT CONCLUDES THE FOLLOWING: ¿BASED ON THE COMPLAINT INFORMATION RECEIVED AND REVIEWED TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THE SINUS DILATION DEVICE DIRECTLY CONTRIBUTED TO THE PATIENT'S DEATH. THE PATIENT WAS A 81-YEAR-OLD MALE WITH SIGNIFICANT UNDERLYING CARDIOVASCULAR COMORBIDITIES, INCLUDING CONGESTIVE HEART FAILURE, HYPERTENSION, AND A PERMANENT PACEMAKER. THE PATIENT UNDERWENT AN IN-OFFICE BALLOON SINUPLASTY PROCEDURE. THERE WERE NO REPORTS OF DEVICE MALFUNCTION, PERFORMANCE ISSUES, OR PROCEDURAL COMPLICATIONS. THE BALLOON CATHETER AND HANDPIECE FUNCTIONED AS INTENDED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. GIVEN THE PATIENT'S AGE AND SUBSTANTIAL PRE-EXISTING CARDIOVASCULAR DISEASE, THESE FACTORS REPRESENT WELL-ESTABLISHED RISK CONTRIBUTORS FOR PERIOPERATIVE CARDIAC EVENTS, INDEPENDENT OF THE SINUS DILATION PROCEDURE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED CARDIAC ARREST CANNOT BE ESTABLISHED." IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN-OFFICE BALLOON SINUPLASTY USING RELIEVA SPINPLUS NAV BALLOON WAS PERFORMED ON A PATIENT. ¿THE PATIENT DIED FROM CARDIAC ARREST AN HOUR AFTER LEAVING THE OFFICE¿. IT WAS CONFIRMED THAT NO MALFUNCTION OF THE DEVICE OCCURRED DURING THE PROCEDURE. BOTH THE BALLOON AND SINUPLASTY SYSTEM FUNCTIONED PROPERLY. THE PATIENT REPORTEDLY DID NOT EXHIBIT ANY SIGNS OR SYMPTOMS DURING THE PROCEDURE. RELEVANT PATIENT MEDICAL AND SURGICAL HISTORY IS AS FOLLOWS: CONGESTIVE HEART FAILURE, HYPERTENSION, CARDIAC PACEMAKER.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383132 SPINPLUS NAV 6X16MM 3 GUIDE RELIEVA PGW ACCLARENT, INC. UNKNOWN 10705031241015

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death