BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP

    MDR report key: 3042303 · Received April 9, 2013

    Report

    Report Number
    3004066202-2013-00044
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 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: ( USE OF THE DEVICE DURING PROCEDURE).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION IN THE PERONEAL ARTERY WHICH EXHIBITED 99% STENOSIS, MODERATE CALCIFICATION AND LITTLE TORTUOSITY. AN AMPHIRION DEEP BALLOON WAS INSERTED AND INFLATED AT THE LESION. WHEN AN ATTEMPT WAS MADE TO REMOVE THE BALLOON IT GOT STUCK WITH THE CHEVALIER 300CM GUIDE WIRE, ALTHOUGH FORCE WAS APPLIED DURING THE ATTEMPTED REMOVAL DEVICE COULD STILL NOT BE REMOVED. THE BALLOON WAS REMOVED TOGETHER WITH THE GUIDE WIRE. THE SHAFT AROUND THE PROXIMAL MARKER BECAME BUNCHED. NO RESISTANCE WAS NOTED AT THE TIME OF BALLOON INSERTION. THE DEVICE WAS NOT MOVED ON THE GW WHEN THE BALLOON WAS INFLATED. NO CLINICAL SEQUELAE WERE REPORTED. DEVICE EVALUATION THE DEVICE LOOKS USED AND THE BALLOON WAS UNFOLDED. THE GUIDEWIRE TUBE UNDER PROXIMAL PART OF THE BALLOON IS CORRUGATED. AFTER THE CUT OF THE GW IN THE PART OUTSIDE THE LUER, A FLUSHING OF THE GW LUMEN WAS PERFORMED BY CONNECTING A SYRINGE FILLED BY WATER TO THE HUB, THE WATER GOES OUT FROM THE TIP. NO LEAKS WERE IDENTIFIED. THE BALLOON WAS INFLATED WITHOUT ANY LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145542 AMPHIRION DEEP CATHETER, PERCUTANEOUS DQY INVATEC SPA 1D035239

    Patients

    Seq Age Sex Outcome Treatment
    1