BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA SOLO BALLOON CATHETER

    MDR report key: 1362661 · Received March 25, 2009

    Report

    Report Number
    1362661
    Event Type
    Malfunction
    Date Received
    March 25, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 24, 2009
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SINUS GUIDE CATHETER WAS INTRODUCED INTO THE SINUS UNDER ENDOSCOPIC VISUALIZATION. A FLEXIBLE SINUS GUIDEWIRE WAS INTRODUCED THROUGH THE SINUS GUIDE CATHETER AND ADVANCED WITHIN THE TARGET SINUS UNDER FLUOROSCOPIC GUIDANCE. THE POSITION OF THE SINUS BALLOON CATHETER WAS CONFIRMED, AND WAS GRADUALLY DILATED, WHEN THE BALLOON BROKE OFF THE END OF THE GUIDE WHILE IN THE SINUS. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE BALLOON AND GUIDE WITHOUT ANY PROBLEMS. THE GUIDE AND BALLOON WERE GIVEN TO THE SURGICAL SERVICE TEAM LEADER TO RETURN TO THE COMPANY FOR AN EVALUATION. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT RELATED TO THE RUPTURE OF THE BALLOON.

    Description of Event or Problem · 1

    THE SINUS GUIDE CATHETER WAS INTRODUCED INTO THE SINUS UNDER ENDOSCOPIC VISUALIZATION. A FLEXIBLE SINUS GUIDEWIRE WAS INTRODUCED THROUGH THE SINUS GUIDE CATHETER AND ADVANCED WITHIN THE TARGET SINUS UNDER FLUOROSCOPIC GUIDANCE. THE POSITION OF THE SINUS BALLOON CATHETER WAS CONFIRMED, AND WAS GRADUALLY DILATED, WHEN THE BALLOON BROKE OFF THE END OF THE GUIDE WHILE IN THE SINUS. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE BALLOON AND GUIDE WITHOUT ANY PROBLEMS. THE GUIDE AND BALLOON WERE GIVEN TO THE SURGICAL SERVICE TEAM LEADER TO RETURN TO THE COMPANY FOR AN EVALUATION. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT RELATED TO THE RUPTURE OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA SOLO BALLOON CATHETER BALLOON CATHETER, SINUS KAO ACCLARENT, INC. GCO20RS *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR