BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 5746540 · Received June 23, 2016

    Report

    Report Number
    0002090040-2016-00007
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    OWQ
    PMA / PMN Number
    K092425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH SUBSEQUENT ENGINEERING, CLINICAL AND RISK REVIEW, IT WAS DETERMINED THAT THE REPORTED EVENT WAS UNRELATED TO THE STRYKER SUSTAINABILITY SOLUTIONS (SSS) DEVICE BASED ON REVIEW OF THE DEVICE INVESTIGATION. THE DEVICE MET ALL SPECIFICATIONS AND REVIEW OF BOTH EEPROM DETERMINED THE DEVICE WAS NOT USED, THEREFORE ROOT CAUSE OF THE EVENT POINTS TO CUSTOMER CONNECTION ERROR TO THE CARTO SYSTEM FOR 3D MAPPING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE WAS NOT CONFIRMED. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO: USER ERROR (INCLUDING USER TECHNIQUE AND METHODS). CONNECTION ERROR (INCLUDING THE CONTACT OF THE PINS TO THE CABLE RECEPTORS OR IMPROPER CONNECTION OF THE INTERCONNECT TAB). ANCILLARY EQUIPMENT ERROR (INCLUDING ALL OTHER EQUIPMENT OUTSIDE OF THE COMPLAINT DEVICE THAT MAY HAVE CONTRIBUTED TO THE ERROR). USER EXPECTATION / ANTICIPATION OF DEVICE IMAGE. THE INSTRUCTIONS FOR USE STATE: INSPECT THE CATHETER FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE CATHETER IF ANY DAMAGE IS NOTED. IF SUCH PROBLEMS EXIST, RETURN THE CATHETER AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS. FOR PROPER CARE AND HANDLING OF THE 3D DIAGNOSTIC ULTRASOUND CATHETER, ALWAYS HOLD THE ULTRASOUND CATHETER BY THE HANDLE AND SUPPORT THE CATHETER SHAFT. AVOID TOUCHING THE 3D DIAGNOSTIC ULTRASOUND CATHETER INTERCONNECT TAB. LIFT THE LEVER ON THE CONNECTOR, SLIPPING IT ONTO THE CATHETER INTERCONNECT TAB UNTIL FULLY MATED WITH THE STEERING HANDLE. PUSH THE LEVER DOWN, LOCKING INTO PLACE. USE THE HYPERTRONIC CATHETER CONNECTOR TO CONNECT THE 3D DIAGNOSTIC ULTRASOUND CATHETER TO THE MAPPING SYSTEM. WHEN THE 3D DIAGNOSTIC ULTRASOUND CATHETER IS USED IN CONJUNCTION WITH THE CARTO XP MAPPING SYSTEM, CONNECT THE CATHETER TO THE PATIENT INTERFACE UNIT (PIU) USING A STERILE EXTENSION CABLE (NOT PROVIDED BY STRYKER SUSTAINABILITY SOLUTIONS). FOR USE OF THE 3D DIAGNOSTIC ULTRASOUND CATHETER IN MAPPING PROCEDURES, AN ADDITIONAL EXTERNAL REFERENCE PATCH (NOT PROVIDED BY STRYKER SUSTAINABILITY SOLUTIONS) IS REQUIRED FOR LOCATION REFERENCE POSITION PURPOSES. CONNECT THE EXTERNAL REFERENCE PATCH (NOT PROVIDED BY STRYKER SUSTAINABILITY SOLUTIONS) FOLLOWING THE APPROPRIATE MAPPING SYSTEM DOCUMENTATION. THE 3D DIAGNOSTIC ULTRASOUND CATHETERS ARE CONNECTED TO STANDARD ULTRASOUND EQUIPMENT USING APPROPRIATE CONNECTORS. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN EMERGENCY CASE, THE DEVICE DID NOT FUNCTION WHEN PLUGGED IN. AFTER A COUPLE ATTEMPTS, ANOTHER DEVICE WAS TRIED AND THE SAME ISSUE OCCURRED. THEREFORE, THE PROCEDURE TYPE WAS SWITCHED TO TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN EMERGENCY CASE, THE DEVICE DID NOT FUNCTION WHEN PLUGGED IN. AFTER A COUPLE ATTEMPTS, ANOTHER DEVICE WAS TRIED AND THE SAME ISSUE OCCURRED. THEREFORE, THE PROCEDURE TYPE WAS SWITCHED TO TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400917 NA REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 10439236 2821315SH

    Patients

    Seq Age Sex Outcome Treatment
    1