BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVX® THROMBECTOMY SET

    MDR report key: 6577494 · Received May 18, 2017

    Report

    Report Number
    2134265-2017-05362
    Event Type
    Injury
    Date Received
    May 18, 2017
    Report Date
    May 16, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K133629
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE WEEK OF THE (B)(6) 2017. FAX NUMBER: (B)(6). 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 THE PATIENT EXPERIENCED INCREASED BLOOD PRESSURE, DISCOMFORT, AND COLLAPSED. AN AVX® THROMBECTOMY SET WAS SELECTED FOR A THROMBECTOMY PROCEDURE FOR EITHER A LOOP GRAFT OR VENOUS GRAFT IN THE PATIENT'S ARTERIOVENOUS (AV) FISTULA. PARTWAY THROUGH THE PROCEDURE, THE PATIENT EXPERIENCED INCREASED BLOOD PRESSURE AND DISCOMFORT. THE PROCEDURE WAS PAUSED FOR THE PATIENT TO FEEL BETTER AND WAS THEN COMPLETED WITH THIS DEVICE. THE PATIENT HAD ABDOMINAL DISCOMFORT. IT WAS NOTED THE PATIENT DID NOT HAVE A URINARY CATHETER IN. THE TOTAL RUN TIME WAS ABOUT 280 SECONDS. POST PROCEDURE WHEN THE PATIENT WAS UP IN THE WARD, THE PATIENT COLLAPSED. AS OF THE TIME OF THE REPORT, THE PATIENT HAD RECOVERED AND WAS COMPLETELY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356438 AVX® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 105039-003 18683837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other