BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPIRA NC RX PTCA DILATION CATHETER 10 X 4.0

    MDR report key: 4109129 · Received September 8, 2014

    Report

    Report Number
    3004036480-2014-00003
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT DID PCI ON (B)(6) 2014. THE BALLOON WAS BURST DURING POST-DILATION AT 18 ATM. THE LESION WAS AT LAD. THE SURGEON TRIED TO WITHDRAW THE DEVICE WITH GC TOGETHER. BUT IT WAS STUCK AT RADIAL ARTERY. THE SURGEON HAD TO USE SURGICAL PROCEDURE TO REMOVE THE DEVICE. NOW THE PT IS STILL HOSPITALIZED FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551415 EMPIRA NC RX PTCA DILATION CATHETER 10 X 4.0 LOX CREGANNA-TACTX MEDICAL 75R10400N CE0003122

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R