BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSON ACUNAV ULTRASOUND CATHETER

    MDR report key: 5828266 · Received July 27, 2016

    Report

    Report Number
    3009498591-2016-00197
    Event Type
    Injury
    Date Received
    July 27, 2016
    Date of Event
    October 29, 2013
    Report Date
    July 26, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K071234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON REQUEST BY THE FDA TO CORRECT THE FOLLOW UP REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE OUTCOME ATTRIBUTED TO ADVERSE EVENT, CORRECT THE COMMON DEVICE NAME AND PROVIDE DEVICE PROCODE, CORRECT THE MANUFACTURER'S CITY, UPDATE THE DEVICE AVAILABLE FOR EVALUATION, CORRECT THE INITIAL REPORTER INFORMATION, CORRECT THE MANUFACTURER'S CITY, UPDATE THE REPORT SOURCE, PROVIDE THE PMA/510(K) INFORMATION, CORRECT THE DEVICE EVALUATED BY MANUFACTURER, UPDATE LABELED FOR SINGLE USE, AND CORRECT THE EVENT AND EVALUATION CODES. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION AS THE HOSPITAL DECIDED NOT TO ALLOW THE DEVICE TO BE SHIPPED BACK.

    Additional Manufacturer Narrative · 1

    THIS MDR IS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE PURPOSE OF IDENTIFYING CONCOMITANT DEVICES. THE REPORTED EVENT DESCRIBES SIDE EFFECTS FROM THE PROCEDURE OR PATIENT SYMPTOMS DUE TO THEIR CONDITION. THIS PRODUCT IS CONSIDERED A CONCOMITANT DEVICE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION AS THE HOSPITAL DECIDED NOT TO ALLOW THE DEVICE TO BE SHIPPED BACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CARDIAC ARREST DURING THE PROCEDURE. CPR AND DRUG WAS ADMINISTERED TO THE PATIENT. THE PATIENT WAS STABILIZED AND UNDER OBSERVATION. THE BWI EQUIPMENT INVOLVED ARE: CARTO 3 SYSTEM (SERIAL# (B)(4)), STOCKERT GENERATOR (SERIAL# (B)(4)), COOLFLOW PUMP (SERIAL# (B)(4)), ACUNAV CATHETER 10235936 (SERIAL# (B)(4)), LASSO ECO CATHETER D134301 (LOT# 15745793L), AND THERMOCOOL SF NAV CATHETER D131503 (LOT# 15919451L). CALLER CALLED BACK THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481147 ACUSON ACUNAV ULTRASOUND CATHETER ULTRASOUND CATHETER OBJ SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV 8F-90

    Patients

    Seq Age Sex Outcome Treatment
    1 Death