BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRO ELITE

    MDR report key: 2713651 · Received August 6, 2012

    Report

    Report Number
    1225894-2012-00001
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    November 22, 2011
    Report Date
    February 15, 2012
    Manufacturer
    RADIUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    MMX
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SNARE LOOP WAS ABRUPTLY BENT AND SEVERED APPROX 22MM DISTAL TO THE LOOP TO CORE ATTACHMENT. PER THE PHYSICIAN DESCRIPTION, THE DEVICE WAS USED FOR MULTIPLE ATTEMPTS WHICH WOULD INVOLVE RIGOROUS MANIPULATIONS. ONCE LOCKED AROUND THE STENT, ADD'L MANIPULATIONS WOULD BE NECESSARY TO FREE THE ONE YEAR OLD STENT FROM THE BODY TISSUES. RIGOROUS MANIPULATIONS WITH THE LOOP TRAPPED AROUND THE STENT WOULD LEAD TO FATIGUE AND EVENTUAL FRACTURE OF THE LOOP FROM THE DEVICE. THE IFU CONTRAINDICATES USING THE SNARE TO REMOVE AN OBJECT THAT IS ENTRAPPED BY TISSUE GROWTH.

    Description of Event or Problem · 1

    THE DOCTOR WAS SNARING A URETERAL STENT THAT HAD BEEN IN PLACE FOR OVER ONE YEAR. SEVERAL SNARES AND ATTEMPTS WERE MADE TO CAPTURE THE STENT UNTIL SUCCESS WAS ACHIEVED. EVENTUALLY THE EXPRO ELITE SNARE FRACTURED DURING RETRIEVAL OF THE STENT FROM THE PT. A FRAGMENT OF THE SNARE LOOP REMAINED IN THE RENAL PELVIS AND WAS REMOVED DURING A FOLLOW UP PROCEDURE THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE RETRIEVAL SNAR MMX RADIUS MEDICAL TECHNOLOGIES, INC. 8403 10W-16752

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR