BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVX® THROMBECTOMY SET

    MDR report key: 5448017 · Received February 19, 2016

    Report

    Report Number
    2134265-2016-01318
    Event Type
    Injury
    Date Received
    February 19, 2016
    Report Date
    February 8, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K133629
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 THAT AN ASPIRATION ISSUE OCCURRED. AN AVX THROMBECTOMY SET WAS SELECTED TO ACCESS A THROMBOSED FISTULA. THE PHYSICIAN PASSED THE CATHETER DISTAL TO PROXIMAL, 1MM-2MM PER SECOND IN THE FULLY THROMBOSED VEIN. AFTER 300 SECONDS, THE VEIN HAD NOT BEEN AFFECTED, WITH NIL THROMBUS REMOVED ANGIOGRAPHICALLY; HOWEVER THE VEIN WAS STILL FULLY OCCLUDED. THE CATHETER WAS BENCH TESTED IN A SMALL TUB OF SALINE/IODINE, THE CATHETER SEEMED TO NOT BE ASPIRATING CORRECTLY AND SHOULD BE ISOVOLUMETRIC. IT SEEMED THE CATHETER WAS ADDING FLUID. AFTER 300 SECONDS, THERE WAS A SMALL COLLECTION OF ABOUT 150-200ML OF WASTE BLOOD. THE PRODUCT WAS DISCARDED. THE PROCEDURE WAS ABANDONED AND THE SURGEON HAD TO RESTORE THE FISTULA FLOW WITH OPEN CUTDOWN AND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105008 AVX® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 105039-003 0000187189

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention