BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWP CATHETER

    MDR report key: 10605550 · Received September 30, 2020

    Report

    Report Number
    1220452-2020-00078
    Event Type
    Injury
    Date Received
    September 30, 2020
    Report Date
    September 30, 2020
    Product Code
    DQO
    UDI-DI
    00613994733658
    PMA / PMN Number
    K884065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PWP CATHETER WAS ATTEMPTED TO BE USED DURING A RHC PROCEDURE FOR IMPLANT OF A NON-MEDTRONIC DEVICE. IT WAS REPORTED THAT MOVEMENT OF THE PWP DEVICE CAUSED A HEART BLOCK. THE PATIENT RECEIVED ATROPINE AND THE ISSUE RESOLVED WITHOUT ANY FURTHER INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070757 PWP CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO 150075 0010082305 00613994733658

    Patients

    Seq Age Sex Outcome Treatment
    1 Other