BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLANAV OI

    MDR report key: 12408525 · Received September 1, 2021

    Report

    Report Number
    2134265-2021-11109
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 3, 2021
    Report Date
    November 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTELLANAV MIF OI CATHETER WAS RECEIVED BY BOSTON SCIENTIFIC FOR ANALYSIS. VISUAL INSPECTION NOTED THE IRRIGATION EXTENSION TUBING WAS PARTIALLY DETACHED FROM THE LUER FITTING AT THE ADHESIVE JOINT. THE REPORTED FIELD OBSERVATION WAS CONFIRMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    DURING AN ABLATION PROCEDURE IT WAS REPORTED THAT IRRIGATION PORT OF THE INTELLANAV OI CATHETER WAS DAMAGED AFTER MAPPING BEGAN. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    DURING AN ABLATION PROCEDURE IT WAS REPORTED THAT IRRIGATION PORT OF THE INTELLANAV OI CATHETER WAS DAMAGED AFTER MAPPING BEGAN. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302614 INTELLANAV OI INTELLANAV OI OAE BOSTON SCIENTIFIC CORPORATION 87045 0026729404

    Patients

    Seq Age Sex Outcome Treatment
    1