BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER GUIDE CATHETER

    MDR report key: 3962819 · Received July 29, 2014

    Report

    Report Number
    1220452-2014-00047
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (INCONCLUSIVE, INVESTIGATION IN PROGRESS); NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (DEVICE DISCARDED); NONE (NO DEVICE RETURNED). CONCLUSION: INCONCLUSIVE- INVESTIGATION IN PROGRESS; DEVICE NOT RETURNED. (B)(4). EVENT DATE ASKED BUT UNABLE TO PROVIDE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE OR CINE IMAGES RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST USE OF A LAUNCHER GUIDE CATHETER, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT A SMALL BLOOD CLOT WAS OBSERVED ON THE END OF THE DEVICE TIP. THE PHYSICIAN SUSPECTED IT MAY HAVE BEEN RELATED TO HEPARIN-SALINE PREPARATION. NO OTHER INFORMATION IS AVAILABLE. NO INTERVENTION OR OTHER CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441959 LAUNCHER GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1