BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP RX

    MDR report key: 2943275 · Received February 5, 2013

    Report

    Report Number
    3004066202-2013-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (TWO DEVICES IN THE ONE 5FR SHEATH). EVALUATION CODE CONCLUSION; 61-USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT (TWO DEVICES IN THE ONE 5FR SHEATH).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION IN THE ATA WITH AN AMPHIRION DEEP DEVICE. THE LESION WAS LOCATED AT THE BIFURACATION, WAS REPORTED TO BE 99 % STENOTIC, WAS NON TORTUOUS AND NON CALCIFIED. THE PHYSICIAN INSERTED THE DEVICE INTO A 5FR SHEATH AND DELIVERED THE DEVICE. NO FRICTION WAS ENCOUNTERED WITH THE GUIDE WIRE OR GUIDE CATHETER. ANOTHER AMPHIRION DEEP DEVICE WAS INSERTED INTO THE SAME SHEATH FOR "KISSING BALLOON" TECHNIQUE. RESISTANCE WAS NOTED AT THE TIME OF BALLOON INSERTION DUE TO THE PRESENCE OF THE 2 DEVICES IN THE SAME 5F SHEATH. AFTER BALLOONING, THE DEVICES WERE STUCK DURING REMOVAL. IT WAS NOT POSSIBLE TO REMOVE THE DEVICES AND THEN THE PHYSICIAN PULLED THE BALLOONS WITH FORCE, RESULTING IN DETACHMENT OF THE FIRST DEVICE. THE PHYSICIAN ATTEMPTED USING A GOOSE NECK FOR RETRIEVAL BUT THIS FAILED. 3M WIRE AND 6F GUIDE CATHETER WAS INSERTED AND SUCCEEDED TO WRAP THE DETACHED PART WITH THE WIRE. THE SECOND DEVICE WAS REMOVED IN ONE PIECE. NO PATIENT INJURY WAS REPORTED. DEVICE EVALUATION: THE DEVICE WAS RETURNED DIVIDED IN TWO PARTS: HYPOTUBE AND DISTAL SHAFT WITH BALLOON. THE BALLOON WAS UNFOLDED AND CONTAINED DRIED BLOOD. THE DEVICE TIP WAS STRETCHED, THE DISTAL SHAFT WAS STRETCHED, MONORAIL ZONE COMPLETELY DESTROYED AND SEPARATED FROM THE HYPOTUBE. THE HYPOTUBE WAS SLIGHTLY KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47872 AMPHIRION DEEP RX CATHETER, PERCUTANEOUS DQY INVATEC SPA 1C025960

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention