BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER

    MDR report key: 20205518 · Received September 12, 2024

    Report

    Report Number
    2124215-2024-57136
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    February 9, 2021
    Report Date
    September 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2021, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE ADMISSION DATE. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 0

    PER PMCF PREMIER EP DATA ANALYSIS, IT WAS REPORTED THAT: PROCEDURE ID#(B)(6). REAL WORLD EVIDENCE - RETROSPECTIVE PATIENT BILLING RECORDS REVIEW OF PREMIER HEALTH DATABASE PATIENT ADMISSION DATE: (B)(6) 2021. PATIENT DISCHARGE DATE: (B)(6) 2021. ADVERSE EVENT INCLUDING: EXTRAVASATION OF OTHER VESICANT AGENT (INITIAL ENCOUNTER), ACUTE EMBOLISM AND THROMBOSIS OF SUPERFICIAL VEINS OF LEFT UPPER EXTREMITY, AND OTHER MEDICAL PROCEDURES AS THE CAUSE OF ABNORMAL REACTION OF THE PATIENT OR OF LATER COMPLICATION WITHOUT MENTION OF MISADVENTURE AT THE TIME OF THE PROCEDURE. PATIENT WAS DISCHARGED TO HOME OR SELF CARE. THE FOLLOWING EVENT, BASED ON RETROSPECTIVE REVIEW OF DATA FROM THE PREMIER HEALTH DATABASE, IS BEING REPORTED AS AN EVENT THAT COULD HAVE POTENTIALLY BEEN PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC AND REPORTED AS AN MDR WHEN THE EVENT OCCURRED. BOSTON SCIENTIFIC REPORTS THE EVENTS IN COMPLIANCE TO 21 CFR 803.3. BECAUSE PREMIER HEALTH DATABASE DATA IS DE-IDENTIFIED BEFORE BEING TRANSMITTED TO BOSTON SCIENTIFIC, THERE ARE SIGNIFICANT LIMITATIONS TO BOSTON SCIENTIFIC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC. ADDITIONALLY, EVENT DATE, EVENT OUTCOME, AND INITIAL REPORTER ARE NOT PROVIDED DUE TO THE TERMS OF THE PREMIER HEALTH DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506380 INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other| H