BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRO ELITE SNARE

    MDR report key: 1029700 · Received April 15, 2008

    Report

    Report Number
    1225894-2008-00002
    Event Type
    Injury
    Date Received
    April 15, 2008
    Report Date
    March 20, 2008
    Manufacturer
    RADIUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    MMX
    PMA / PMN Number
    071457
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE IS BEING RETAINED BY THE FACILITY. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SNARE TIP SEPARATION. TIME OF DEVICE MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: FOREIGN BODY REMOVAL. IT WAS REPORTED THAT DURING AN ATTEMPT TO RETRIEVE AN INFERIOR VENA CAVA FILTER WITH THE EXPRO ELITE SNARE, THE SNARE WAS BEING TORQUED AND THE TIP OF THE SNARE DETACHED FROM THE BODY OF THE DEVICE. THE DETACHED TIP PIECE WAS RETRIEVED WITH A NON-ABBOTT SNARE AND REMOVED FROM THE PT'S ANATOMY. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE SNARE MMX RADIUS MEDICAL TECHNOLOGIES, INC. NA 07W14200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention