BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® SOLENT¿ OMNI

    MDR report key: 6174119 · Received December 14, 2016

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    Report

    Report Number
    2134265-2016-11699
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    November 25, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K111182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 WAS SELECTED FOR AN ARTERIAL THROMBECTOMY PROCEDURE. THE CATHETER WAS PRIMED THEN RAN IN THROMBECTOMY MODE FOR ABOUT 20-30 SECONDS AND A CHECK SALINE ERROR OCCURRED. THE CATHETER LOST ASPIRATION POWER. A RE-PRIME AND RESET WERE ATTEMPTED; HOWEVER THE ERROR REMAINED. SALINE WAS NOTED TO BE LEAKING FROM IN THE TRAY OF THE ANGIOJET CONSOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824542 ANGIOJET® SOLENT¿ OMNI CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 109681-001 19776361

    Patients

    Seq Age Sex Outcome Treatment
    1