BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 839702 · Received April 19, 2007

    Report

    Report Number
    6000089-2007-00570
    Event Type
    Malfunction
    Date Received
    April 19, 2007
    Date of Event
    March 26, 2007
    Report Date
    March 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D2 LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, D4 MAVERICK 15 / 2.0. G5. P860019/S179. THE FACILITY HAS CONFIRMED THAT THIS DEVICE HAS BEEN DISPOSED OF; THEREFORE, NO DIRECT PRODUCT ANALYSIS CAN BE COMPLETED AND NO ROOT CAUSE DETERMINATION CAN BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A PCI PROCEDURE, THE PHYSICIAN NOTICED A PIECE OF HAIR STUCK TO THE HOOP OF THE MAVERICK2 MONORAIL CATHETER PACKAGING. THIS OCCURRED DURING PREPARATION, AND "IT WAS UNK WHETHER A HAIR WAS IN A PACKAGE FROM THE BEGINNING". THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND PATIENT STATUS WAS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX BOSTON SCIENTIFIC MAVERICK2 15 / 2.0 9220340

    Patients

    Seq Age Sex Outcome Treatment
    1 YR GUIDEWIRE: NEO'S RINATO| GUIDE CATHETER: BRITE TIP| BALLOON CATHETER: SPRINTER 2.0*15| STENT: CYPHER