BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRO ELITE SNARE

    MDR report key: 1181179 · Received September 30, 2008

    Report

    Report Number
    1225894-2008-00004
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SNARE DETACHMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: ARTERIAL DISSECTION, PERFORATION, SURGICAL VESSEL REPAIR AND DEVICE REMOVAL. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE IN THE LEFT COMMON ILIAC ARTERY, A NON-ABBOTT GLIDE CATHETER DETACHED IN THE BODY. A PHYSICIAN, IN TRAINING IN THE USE OF THE EXPRO ELITE SNARE, ATTEMPTED TO RETRIEVE THE DETACHED CATHETER. THE EXPRO ELITE SNARE WAS FORCED AROUND THE DETACHED DEVICE MULTIPLE TIMES AND THE NITINOL LOOP OF THE SNARE DETACHED IN THE VESSEL. AT AN UNKNOWN TIME DURING THE PROCEDURE, AN ARTERIAL DISSECTION AND PERFORATION OCCURRED. THE DETACHED PORTIONS OF BOTH DEVICES WERE SURGICALLY REMOVED AND THE VESSEL WAS SURGICALLY REPAIRED. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE SNARE MMX RADIUS MEDICAL TECHNOLOGIES, INC. NA 07W14256

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NON-ABBOTT GLIDE CATHETER