BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® SOLENT¿ OMNI

    MDR report key: 6145077 · Received December 5, 2016

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    Report

    Report Number
    2134265-2016-10842
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K111182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING ASPIRATION. AN ANGIOJET® SOLENT¿ OMNI CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. POWER PULSE WAS PERFORMED BY SPRAYING TISSUE PLASMINOGEN ACTIVATOR (TPA) INTO THE CLOT. AFTER 20 MINUTES, THEY INITIATED ASPIRATION INSIDE THE PATIENT. HOWEVER, ASPIRATION STOPPED WHEN A CHECK TUBING OR CHECK SEAL ERROR MESSAGE DISPLAYED. A LEAK WAS OBSERVED AT THE PUMP. THEY SWITCHED TO AN ASPIRATION CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796238 ANGIOJET® SOLENT¿ OMNI CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 109681-001 19758402

    Patients

    Seq Age Sex Outcome Treatment
    1