BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVX® THROMBECTOMY SET

    MDR report key: 6177859 · Received December 15, 2016

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    Report

    Report Number
    2134265-2016-11470
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Report Date
    November 23, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K133629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-11469. IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED DURING ASPIRATION. AN AVX® THROMBECTOMY SET CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN A DIALYSIS PATIENT. AFTER A FEW PUMPS INSIDE THE PATIENT, A 'CHECK SALINE' ERROR MESSAGE DISPLAYED. SOME LEAKING WAS NOTED. A SECOND AVX® THROMBECTOMY SET CATHETER WAS SELECTED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD AVX® THROMBECTOMY SET CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829848 AVX® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 105039-001 19863729

    Patients

    Seq Age Sex Outcome Treatment
    1