BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® SOLENT¿ OMNI

    MDR report key: 6011851 · Received October 7, 2016

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    Report

    Report Number
    2134265-2016-09352
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 26, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K111182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.:RETURNED PRODUCT CONSISTED OF A SOLENT OMNI THROMBECTOMY SYSTEM AND NO OTHER DEVICES. THE PUMP, SHAFT, AND TIP WERE MICROSCOPICALLY EXAMINED AND NO DAMAGE OR IRREGULARITIES WERE 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 AN INDICATION THAT THE OUTLET ADAPTER SEAL FAILED. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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 THERE WAS A LOSS OF ASPIRATION. AN ANGIOJET® SOLENT¿ OMNI CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN A LOWER LIMB VEIN. DURING THE PROCEDURE WHEN THE DEVICE WAS INSIDE THE PATIENT, ASPIRATION WAS ACHIEVED AND THEN COMPLETELY LOST. A LEAK AT THE PUMP WAS NOTED. HOWEVER, NO ERROR MESSAGE DISPLAYED ON THE CONSOLE. THE CONSOLE WORKED WELL, BUT THE THROMBUS COULD NOT BE ASPIRATED NORMALLY DUE TO THE LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS NOTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF ASPIRATION. AN ANGIOJET® SOLENT¿ OMNI CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN A LOWER LIMB VEIN. DURING THE PROCEDURE WHEN THE DEVICE WAS INSIDE THE PATIENT, ASPIRATION WAS ACHIEVED AND THEN COMPLETELY LOST. A LEAK AT THE PUMP WAS NOTED. HOWEVER, NO ERROR MESSAGE DISPLAYED ON THE CONSOLE. THE CONSOLE WORKED WELL, BUT THE THROMBUS COULD NOT BE ASPIRATED NORMALLY DUE TO THE LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS NOTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662599 ANGIOJET® SOLENT¿ OMNI CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 109681-007 18735700

    Patients

    Seq Age Sex Outcome Treatment
    1