BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR D/L POWERPICC SOLO FULL TRAY

    MDR report key: 2230460 · Received August 15, 2011

    Report

    Report Number
    3006260740-2011-00270
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    August 9, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL AS IT IS BEING RETAINED BY REPORTING FACILITY. A LOT HISTORY REVIEW (LHR) OF REVE1211 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    DURING THE INITIAL INSERTION AT BEDSIDE, THE GW COULD NOT ADVANCE. PT SENT TO SPECIAL PROCEDURES TO REPOSITION. THEY USED FLUORO, AND SAW THE MAGNETIC TIP HAD SEPARATED. THE FACILITY FLUSHED THE TIP AND IT MIGRATED INTO THE PT. ADDITIONAL INFO: INSERTION WAS DIFFICULT AND COULD NOT BE DONE AT BEDSIDE. IR NOTED THAT INITIALLY THE WIRE BROKE INSIDE THE CATHETER, AND THEN EMBOLIZED WHEN THE CATHETER WAS FLUSHED. THE RETAINED WIRE WILL BE LEFT IN THE PT, PER MD'S CLINICAL DECISION. PT IS STABLE AND ASYMPTOMATIC. THE RETAINED WIRE PIECE IS APPROXIMATELY 1 CM IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR D/L POWERPICC SOLO FULL TRAY LJS C. R. BARD INC. (BASD) REVE1211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention