BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 4275861 · Received November 20, 2014

    Report

    Report Number
    2134070-2014-00190
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    PMA / PMN Number
    K110076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SENT AFTER DEVICE INVESTIGATION IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED DURING THE CASE. ACCESS HAD BEEN OBTAINED, A CORONARY SINUS CATHETER HAD BEEN PLACED INTO THE CS UNDER FLUOROSCOPIC GUIDANCE. ULTRASOUND IMAGES HAD BEEN OBTAINED AND INCORPORATED INTO A CARTO MAP OF THE LEFT ATRIUM. A SINGLE RF APPLICATION HAD BEEN APPLIED. CARTOSOUND CONFIRMED CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND MORE THAN 900 CC OF FLUID WAS REMOVED. THE PATIENT WAS STABILIZED. THE PROCEDURE WAS COMPLETED AFTER THE TAMPONADE WITHOUT ANY FURTHER INJURY. IT WAS ALSO REPORTED THAT INITIALLY THERE WAS EXTREME DIFFICULTY STEERING THE DEVICE BEFORE THE TAMPONADE OCCURRED AND THAT THE DEVICE WAS EXCHANGED WITH ANOTHER DEVICE WITH NO ISSUE AFTER THE TAMPONADE. THE REPLACEMENT WAS MADE IN ORDER TO VISUALIZE THE PERICARDIAL SPACE FOR EVALUATION OF THE VOLUME OF FLUID PRESENT. THE SURGEON DID NOT BELIEVE THAT THE DEVICE CAUSED THE CARDIAC TAMPONADE DESPITE THE DIFFICULTY IN STEERING. IT WAS BELIEVED THAT THE ISSUE WAS A COMBINATION OF HOW THE ABLATION CATHETER WAS MOVED DURING MAPPING COMBINED WITH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752076 NA REPROCESSED INTRAVASCULAR ULTRASOUND OWQ STERILMED, INC. BIOSNDSTR10 1772136

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R WEBSTER CS CATHETER D135303, LOT#17066846M| BIOSENSE WEBSTER CARTO 3 SYSTEM, SN# (B)(4)| COOLFLOW PUMP, SN#02005| STOCKERT GENERATOR SN# (B)(4)| SMART TOUCH CATHETER D133602, LOT#17030933M,