BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTECH ESOPHAGEAL BALLOON DILATOR

    MDR report key: 18365211 · Received December 19, 2023

    Report

    Report Number
    MW5149396
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    September 11, 2023
    Report Date
    December 15, 2023
    Manufacturer
    MICRO-TECH (NAN JING) CO., LTD.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT WAS IN PROCEDURE, NEEDED DILATION. MD INSTRUCTED BALLOON BE INFLATED TO 18 IN LOWER ESOPHAGUS. THIS WAS DONE WITHOUT PROBLEM. BALLOON DEFLATED AND MOVED UP TO MID ESOPHAGUS AREA AND MD AGAIN INSTRUCTED BALLOON TO BE INFLATED TO 18. RN AT BEDSIDE DID THIS AND NOTIFIED MD THAT SHE FELT RESISTANCE CLOSE TO THE 18 MARK, SHE STOPPED AND WHILE WAS HOLDING IT AT 18 FOR A FEW SECONDS, IT BUSTED WHILE IN PATIENT. BALLOON DID NOT SEPARATE IN PIECES, WAS INTACT. PT DROPPED SATS FOR A BRIEF PERIOD AND THEN WENT BACK TO 90S. PT WAS COUGHING IN RECOVERY BUT SP02 SATS WERE MID 90S. DEVICE WAS BEING USED PER MANUFACTURER INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279168 MICROTECH ESOPHAGEAL BALLOON DILATOR DILATOR, ESOPHAGEAL KNQ MICRO-TECH (NAN JING) CO., LTD. M221204323

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male