BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF-STAR EXTERNAL REFERENCE PATCH

    MDR report key: 1233942 · Received November 14, 2008

    Report

    Report Number
    9673241-2008-00050
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K982415
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END OF THE CONNECTOR CAME OUT OF THE HANDLE EXPOSING THE CORE OF THIS REFERENCE PATCH. THE CUSTOMER STATED THAT THIS PRODUCT WAS ON THE PATIENT BUT IT DID NOT CAUSE DAMAGE TO THE PATIENT. THE CUSTOMER STATED THAT THEY COULD SEE DRIED GLUE IN THE HANDLE. THE CUSTOMER ALSO STATED THAT AN EMERGENCY SITUATION OCCURRED, BUT THEY DID NOT PROVIDE ANY DETAILS ABOUT THE SITUATION. CUSTOMER STATED THAT THE BIOSENSE WEBSTER PRODUCTS HAD NOTHING TO DO WITH THE EMERGENCY SITUATION. ADDITIONAL INFORMATION REGARDING THIS EVENT WAS SUBSEQUENTLY OBTAINED FROM CUSTOMER. THERE WAS A PERFORATION THAT OCCURRED DURING THE TRANSSEPTAL PUNCTURE, AT WHICH POINT, THE PROCEDURE WAS CANCELLED. THE PATIENT WAS TREATED BY PERICARDIOCENTESIS. THE PATIENT IS DOING WELL AND THE DOCTOR DID NOT FORESEE ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REF-STAR EXTERNAL REFERENCE PATCH CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1210-01 13354755

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention