BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUNCHER 6F (JR4.0)

    MDR report key: 2043092 · Received March 15, 2011

    Report

    Report Number
    1220452-2011-00016
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. METHOD AND CONCLUSION: OTHER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PREPARATION OF THE GUIDE CATHETER, A HAIR LINE FRACTURE WAS NOTICED AT THE HUB OF THE CATHETER. NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUNCHER 6F (JR4.0) DQY MEDTRONIC INC. NA 0005234019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA