BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRO ELITE SNARE

    MDR report key: 2997974 · Received March 5, 2008

    Report

    Report Number
    1225894-2008-00005
    Event Type
    Injury
    Date Received
    March 5, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: APPROX 2 CM OF THE DISTAL LOOP PORTION WAS SEVERED FROM THE END OF THE SNARE. THE REMAINDER OF THE LOOP WAS SECURELY ATTACHED TO THE CENTRAL CORE WIRE. THE SNARE HANDLE HAD BEEN PULLED BACKWARD RESULTING IN EXPOSURE OF THE CENTRAL CORE. THE HANDLE PORTION ON THE OUTER SHEATH WAS SEVERELY BENT. THE LOOP WAS CLEANLY SEVERED THROUGH BOTH OF THE LOOP LEGS AS WELL AS THE PLATINUM OUTER COIL AT THE SAME LOCATION. THE 90 DEGREE BENDS ON THE SEVERED LOOP ENDS SUGGEST THAT THE LOOP WAS ABRUPTLY BENT OVER THE END OF THE SNARE OUTER SHEATH WHILE THE LOOP WAS UNDER TENSION. THE POSSIBLE CAUSE OF SEVERING THE LOOP WOULD BE THE ADVANCEMENT OF A FIRM, SHARP OBJECT OVER THE SNARE SHAFT STRONG ENOUGH TO SLICE THROUGH THE LOOP WIRES AND PLATINUM COILS. IT IS UNLIKELY THAT THE LOOP WAS FRACTURED DUE TO TENSION, BENDING, FLEXING, OR TORQUING ALONE AS THIS WOULD NOT TYPICALLY RESULT IN BOTH LOOP LEGS BREAKING AT THE EXACT SAME LOCATION NOR WOULD THE PLATINUM COIL WIRE ALSO CLEANLY SEVER AT THIS LOCATION. ENGINEERING ATTEMPTS TO REPLICATE THE FAILURE EMPLOYING TENSION, BENDING, FLEXING, AND TORQUING WERE UNABLE TO ACHIEVE A SIMILAR FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE BREAKAGE. TIME OF MALFUNCTION: DURING 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 SEPARATED INTO TWO PIECES AT THE FILTER SITE. THE EXPRO SNARE CENTRAL CORE WAS REMOVED AND THE DETACHED LOOP PORTION WAS RETRIEVED FROM THE ANATOMY USING ANOTHER SNARE DEVICE. THERE WAS NO PT EFFECT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE SNARE MMX RADIUS MEDICAL TECHNOLOGIES, INC. NA 07W14202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention UNK FILTER PROTECTION DEVICE