BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® SOLENT¿ OMNI

    MDR report key: 6122090 · Received November 22, 2016

    Report

    Report Number
    2134265-2016-10679
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K111182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ERROR MESSAGE OCCURRED DURING ASPIRATION. AN ANGIOJET® SOLENT¿ OMNI WAS BEING USED IN A THROMBECTOMY PROCEDURE TREATING THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE WHILE ACTIVELY ASPIRATING THE LESION, A CHECK SALINE SUPPLY OCCURRED. THE DEVICE WAS UNABLE TO FUNCTION. ANOTHER ANGIOJET CATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773289 ANGIOJET® SOLENT¿ OMNI CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 109681-001 19776335

    Patients

    Seq Age Sex Outcome Treatment
    1