BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12776098 · Received November 8, 2021

    Report

    Report Number
    3011610434-2021-00020
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 15, 2021
    Report Date
    November 8, 2021
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    OWQ
    UDI-DI
    10841898123252
    PMA / PMN Number
    K202042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH, LLC BECAME AWARE ON (B)(6) 2021 OF A REPORT FROM (B)(6) HOSPITAL CENTER ON A VIEWFLEX XTRA ICE DEVICE THAT EXPERIENCED A TIP FRACTURE WHILE IN USE DURING A PROCEDURE. PER THE FEEDBACK RECEIVED FROM THE HOSPITAL, THIS DEVICE WAS REPORTED TO HAVE BEEN INSIDE THE PATIENT WHEN THE TIP FRACTURED. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR EVALUATION ON 26-OCT-2021. UPON INVESTIGATION, THE FRACTURE ON THE DEVICE WAS CONFIRMED. THE TIP DID NOT FALL OFF COMPLETELY AND WAS ATTACHED TO THE SHAFT. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    THE TIP OF THIS DEVICE WAS REPORTEDLY KINKED WHILE ADVANCING IT INTO THE HEART FROM VEIN ACCESS. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669688 NA DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown