BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLO BALLOON GUIDE CATHETER

    MDR report key: 12830083 · Received November 17, 2021

    Report

    Report Number
    2029214-2021-01484
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    November 5, 2021
    Report Date
    November 17, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K120781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT OF A CHELLO BALLOON BURST DURING PREP. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731262 CELLO BALLOON GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 1610590 500307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown