BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROFLEX® ANGIOJET® THROMBECTOMY SET

    MDR report key: 6050373 · Received October 24, 2016

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    Report

    Report Number
    2134265-2016-09481
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 24, 2016
    Report Date
    September 26, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K072769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF SPIROFLEX THROMBECTOMY SYSTEM AND NO OTHER DEVICES. THE PUMP, SHAFT, AND TIP WERE MICROSCOPICALLY EXAMINED AND NO DAMAGE OR IRREGULARITIES IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED BY PLACING THE DEVICE IN THE CONSOLE. FUNCTIONAL TESTING SHOWED A LEAK AT THE MALE CONNECTOR WITH FEMALE LUER. FLUID LEAKING FROM THE CONNECTOR IS IN INDICATION THAT THE OUTLET ADAPTER SEAL FAILED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS A DESIGN CONSTRAINT OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING ASPIRATION. A SPIROFLEX ANGIOJET THROMBECTOMY SET WAS SELECTED FOR USE DURING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY. ASPIRATION WAS PERFORMED FOR A SHORT TIME WHEN THE SYSTEM CONTINUED TO GET THE "CHECK SALINE SUPPLY" ERROR. THE CATHETER WAS RE-INSTALLED MULTIPLE TIMES AND CONTINUED TO GET THE SAME ERROR. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED BALLOONS AND STENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING ASPIRATION. A SPIROFLEX® ANGIOJET® THROMBECTOMY SET WAS SELECTED FOR USE DURING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY. ASPIRATION WAS PERFORMED FOR A SHORT TIME WHEN THE SYSTEM CONTINUED TO GET THE "CHECK SALINE SUPPLY" ERROR. THE CATHETER WAS RE-INSTALLED MULTIPLE TIMES AND CONTINUED TO GET THE SAME ERROR. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED BALLOONS AND STENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700974 SPIROFLEX® ANGIOJET® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 106553-001 19088455

    Patients

    Seq Age Sex Outcome Treatment
    1