BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, PERCUTANEOUS

    MDR report key: 15635760 · Received October 19, 2022

    Report

    Report Number
    15635760
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 22, 2022
    Report Date
    September 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THREE SEPARATE TRAPPER BALLOON DEVICES FAILED TO HOLD PRESSURE IN THE BALLOON. MANUFACTURER RESPONSE FOR TRAPPER EXCHANGE DEVICE 6F-8F, (BRAND NOT PROVIDED) (PER SITE REPORTER) ISSUED RGA# (B)(4), SENDING IN N/C REPLACEMENTS. MANUFACTURER RESPONSE FOR TRAPPER EXCHANGE DEVICE 6F - 8F, (BRAND NOT PROVIDED) (PER SITE REPORTER) ISSUED RGA# (B)(4), SENDING IN N/C REPLACEMENTS. MANUFACTURER RESPONSE FOR TRAPPER EXCHANGE DEVICE 6F -8F, (BRAND NOT PROVIDED) (PER SITE REPORTER) ISSUED RGA# (B)(4), SENDING IN N/C REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2920665 CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION 357103-0756

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA Male