BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® SOLENT¿ OMNI

    MDR report key: 6101401 · Received November 15, 2016

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    Report

    Report Number
    2134265-2016-10095
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K111182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: 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 WITHIN A RIGHT FEMORAL VESSEL. PRIMING WAS COMPLETED. DURING THE PROCEDURE WHEN THE DEVICE WAS INSIDE THE PATIENT'S BODY AFTER ASPIRATION WAS INITIATED, A MESSAGE TO SPIKE SALINE AND SPIKE THE BAG DISPLAYED. THREE ALARM RESETS WERE PERFORMED, BUT THE MESSAGE STILL DISPLAYED AND ONLY 5 SECONDS OF ASPIRATION OCCURRED. THE FOURTH TIME THE RESET WAS ATTEMPTED A MESSAGE TO REPLACE THROMBECTOMY SET DISPLAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752456 ANGIOJET® SOLENT¿ OMNI CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 109681-001 18881243

    Patients

    Seq Age Sex Outcome Treatment
    1