BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS DIRECT SL II

    MDR report key: 3223266 · Received July 12, 2013

    Report

    Report Number
    2017865-2013-04954
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DQY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF THE OUTER GUIDE CATHETER, THE CORONARY SINUS EXPERIENCED A MINIMAL DISSECTION. THE PATIENT DID NOT DECOMPENSATE THUS THE DISSECTION WAS NOT EMERGENTLY REPAIRED; IT WAS FELT THAT THE DISSECTION WOULD CLOSE ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323399 CPS DIRECT SL II CATHETER DQY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DS2C003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention