BEUDAMED
    FDA Adverse Event Injury Summary report: N

    087 BALLOON GUIDE CATHETER

    MDR report key: 11401849 · Received March 2, 2021

    Report

    Report Number
    3015614180-2021-00041
    Event Type
    Injury
    Date Received
    March 2, 2021
    Date of Event
    December 6, 2020
    Report Date
    March 2, 2021
    Manufacturer
    QAPEL MEDICAL INC
    Product Code
    DQY
    PMA / PMN Number
    K192525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DISSECTION OCCURRED IN THE LOCATION THAT MATCHED THE BALLOON POSITION AT THE JUNCTION OF THE DISTAL CERVICAL INTERNAL CAROTIC ARTERY AND THE VERTICAL PETROUS. THIS REQUIRED INTERVENTION TO TREAT THE DISSECTION. A STENT WAS DEPLOYED AND THE CONDITION WAS RESOLVE. THE PATIENT WAS REPORTED AS "DOING WELL." THE DEVICE WAS NOTED AS PERFORMING AS EXPECTED. IT WAS REPORTED THAT THE VOLUME USED TO INFLATE THE BALLOON WAS NOT MEASURED. MAXIMUM INFLATION VOLUME IS DEFINED IN THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294494 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER DQY QAPEL MEDICAL INC BG 8087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention