BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MO.MA. ULTRA 6F ID

    MDR report key: 3772017 · Received April 25, 2014

    Report

    Report Number
    3004066202-2014-00063
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    July 10, 2013
    Report Date
    June 17, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO ISSUES NOTED DURING BALLOON INFLATION THEREFORE EVENT MOST LIKELY DUE TO PROCEDURAL CONTEXT. PATIENT LESION MORPHOLOGY, CALCIFIED LESION WITH 80% STENOSIS. NO DEVICE OR CINE IMAGES RETURNED FOR EVALUATION. NO DEVICE RETURN. CONCLUSION: PATIENT LESION MORPHOLOGY, CALCIFIED LESION WITH 80% STENOSIS. NO ISSUES NOTED DURING BALLOON INFLATION THEREFORE EVENT MOST LIKELY DUE TO PROCEDURAL CONTEXT. (B)(4).

    Description of Event or Problem · 1

    THE INDEX PROCEDURE WAS CARRIED OUT TO TREAT A LESION IN THE RIGHT ICA TO CCA WITH A DISTAL VESSEL DIAMETER 4.9MM AND PROXIMAL DIAMETER 8.4MM. THE LESION WAS CALCIFIED WITH 80% STENOSIS AND TYPE OF AORTA WAS TYPE II. THE MOMA WAS USED WHEN THE GUIDE WIRE WAS PASSED THE LESION; OTHER DEVICES WERE PASSED TO THE LESION, DURING THE PRE-DILATATION, DURING THE STENTING, POST DILATATION AND ASPIRATION. THE PROXIMAL AND DISTAL BALLOON WAS INFLATED SUCCESSFULLY, HOWEVER THE PHYSICIAN WAS UNABLE TO OCCLUDE BLOOD FLOW AT THE SUPERIOR THYROID ARTERY, THEREFORE ANOTHER NON MDT DISTAL PROTECTION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE LESION WAS SUCCESSFULLY STENTED WITH A NON MDT STENT. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

    Description of Event or Problem · 1

    INVESTIGATOR ASSESSED THAT THE EVENT WAS DUE TO PATIENT VESSEL MORPHOLOGY ( ARTERIA THYROIDEA SUPERIOR WAS BELOW THE ECA BALLOON).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251649 MO.MA. ULTRA 6F ID CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR