BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOMA

    MDR report key: 2243939 · Received September 6, 2011

    Report

    Report Number
    MW5022150
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 19, 2011
    Manufacturer
    MEDTRONIC SURGICAL TECHNOLOGIES
    Product Code
    NTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A LEFT CAROTID ANGIOPLASTY WITH MOMA DEVICE (INVATECH/MEDTRONIC). COMMON CAROTID BALLOON INFLATED IN A DEFORMED FASHION. BALLOON CONFIGURATION PROBABLY A RESULT OF MFG PROBLEM. PROCEDURE PROCEEDED UNEVENTFULLY BUT A STROKE RISK WAS PRESENT DUE TO BALLOON MALFUNCTION. MOMA DEVICE DELIVERED INTO PT. COMMON CAROTID ARTERY BALLOON INFLATED BUT BALLOON MALFUNCTIONED. CAROTID ANGIOPLASTY CONTINUED DESPITE MALFUNCTIONING BALLOON BECAUSE REMOVAL OF BALLOON WAS JUDGED TOO DANGEROUS. BALLOON MALFUNCTION INCREASED STROKE RISK CONSIDERABLY. MEDTRONIC INFORMED BUT NO REP EVALUATED THE DEVICE IN PERSON (DESPITE TWO QUERIES TO THEM). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOMA MOMA NTE MEDTRONIC SURGICAL TECHNOLOGIES 1B006531

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening