BEUDAMED
    FDA Adverse Event Death Summary report: N

    CROSSBOSS CATHETER

    MDR report key: 3944296 · Received July 18, 2014

    Report

    Report Number
    2134265-2014-04438
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A STINGRAY CATHETER WAS ALSO USED. IN THE CLINICIAN'S OPINION, THE USE OF THE BSC DEVICES DID NOT CONTRIBUTE TO THE IVC LACERATION.

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2014-04450. IT WAS REPORTED THAT THE PATIENT DIED. A CROSSBOSS AND STINGRAY HAD BEEN USED IN THE PROCEDURE. NO COMPLICATIONS WERE IMMEDIATELY NOTED AT THE END OF THE PROCEDURE. OVERNIGHT, THE PATIENT'S CONDITION DETERIORATED. A LITER OF FLUID/BLOOD WAS DRAINED OFF THE PATIENT'S HEART DUE TO INTERNAL BLEEDING. THE PATIENT DIED. AN AUTOPSY REVEALED THE CAUSE OF DEATH WAS A LACERATED IVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421252 CROSSBOSS CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749M2000A0

    Patients

    Seq Age Sex Outcome Treatment
    1 Death