BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER 15X3.00

    MDR report key: 3839217 · Received May 19, 2014

    Report

    Report Number
    3004036480-2014-00001
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 16, 2014
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT IS MALE AND (B)(6) YEARS OLD, DID PCI ON (B)(6) 2014. THE BALLOON WAS ANNULARLY BURST AT 18 ATM. THE DEVICE WAS DIFFICULT TO WITHDRAW BECAUSE THE BALLOON ENVELOPED THE TIP OF THE GC. THE DEVICE WAS BROKEN AT THE RADIAL ARTERY, AND THE TIP OF THE BALLOON WAS LEFT IN THE PT'S BODY. THE PT DID ANOTHER PROCEDURE 3 DAYS LATER TO TAKE OUT THE BROKEN PIECE. NOW THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295406 EMPIRA NC RX PTCA DILATATION CATHETER 15X3.00 CATHETER, PTCA, PRODUCT CODE: LOX LOX CREGANNA-TACTX MEDICAL EMPIRA NC RX PTCA CE0002746

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention