BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 1852143 · Received September 29, 2010

    Report

    Report Number
    2024168-2010-02034
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 6, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RX MINI TREK BALLOON CATHETER WENT THROUGH THE OCCLUSION WITHOUT ANY RESISTANCE. UPON FIRST DILATATING THE BALLOON TO 8 ATMOSPHERES, FLUID WAS SEEN GOING TO THE VESSEL FROM THE BALLOON. THE DEVICE WAS REMOVED FROM THE PT. ANOTHER RX MINI TREK WAS USED AND DILATATION WAS SUCCESSFULLY COMPLETED. THERE WERE NO PT EFFECTS REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0052161

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR GUIDE WIRE: JOICE