BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFLECTABLE TIP EP CATHETER

    MDR report key: 97447 · Received June 12, 1997

    Report

    Report Number
    2020638-1997-00003
    Event Type
    Injury
    Date Received
    June 12, 1997
    Date of Event
    April 2, 1997
    Report Date
    June 11, 1997
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ELECTROPHYSIOLOGY STUDY AND CATHETER ABLATION, A "POP" WAS FELT AT THE SHAFT OF THE ABLATION CATHETER (AFTER 4TH ENERGY APPLICATION). THE PT BECAME HYPOTENSIVE AND AN EMERGENCY STERNOTOMY WAS PERFORMED FOR REPAIR OF THE RIGHT VENTRICULAR OUTFLOW TRACT. NO FURTHER INFO WAS OBTAINED FROM THE CONTACT PERSON AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFLECTABLE TIP EP CATHETER ELECTROPHYSIOLOGY CATHETER DRF CORDIS WEBSTER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention