BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX 44

    MDR report key: 22148601 · Received June 5, 2025

    Report

    Report Number
    22148601
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 22, 2025
    Report Date
    May 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDICAL DOCTOR [REDACTED] WAS DOING AN ERCP [ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY] PROCEDURE ON [REDACTED], AND WENT HE WENT TO USE THE BOSTON SCIENTIFIC HYDRATOME RX 44 (REF# M00583040, EXP 03-25-2028, LOT #36155477), THE DEVICE WOULD NOT FUNCTION CORRECTLY. THE CUTTING WIRE WOULD NOT "BOW" LIKE IT WAS INTENDED TOO. WE HAD TO OPEN ANOTHER BOSTON SCIENTIFIC HYDRATOME RX 44 (REF #M00583040, LOT #36096758, EXPIRATION 03-17-2028). THAT PRODUCT THEY COULD GET THE WIRE TO "BOW" BUT IT WAS VERY LIMITED REQUIRING US TO OPEN A THIRD DEVICE AND THAT DEVICE WORKED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72684 HYDRATOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00583040 36155477

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown