BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET

    MDR report key: 15224356 · Received August 15, 2022

    Report

    Report Number
    2134265-2022-08461
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    July 1, 2013
    Report Date
    August 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED USING FIRST DATE IN DATE RANGE OF RETROSPECTIVE STUDY: 07/01/2013 THROUGH 12/31/2018. INITIAL REPORTER FACILITY NAME: DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE MEDICINE, INSTITUTE OF CLINICAL SCIENCES, SAHLGRENSKA ACADEMY, UNIVERSITY OF GOTHENBURG AND SAHLGRENSKA UNIVERSITY HOSPITAL. EINARSSON, F., SANDSTROM, C., SVENNERHOLM, K., ORAS, J., & RYLANDER, C. (2020). OUTCOMES OF CATHETER-DIRECTED INTERVENTIONS IN HIGH-RISK PULMONARY EMBOLISM-A RETROSPECTIVE ANALYSIS. ACTA ANAESTHESIOLOGICA SCANDINAVICA, 65(4), 499-506. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1111/AAS.13753.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT ONE PATIENT REACTED TO RHEOLYTIC FRAGMENTATION WITH AN EPISODE OF ASYSTOLE. FIRST-LINE TREATMENT OF HIGH-RISK PULMONARY EMBOLISM WITH PERSISTENT HYPOTENSION AND/OR SIGNS OF SHOCK IS INTRAVENOUS THROMBOLYSIS. HOWEVER, IF THROMBOLYSIS IS CONTRAINDICATED DUE TO RISK OF SERIOUS BLEEDING, OR IF IT YIELDS INSUFFICIENT EFFECT, SURGICAL THROMBECTOMY OR CATHETER-DIRECTED INTERVENTION (CDI) PLUS ANTICOAGULATION IS RECOMMENDED. THE AIM OF THIS STUDY WAS TO ASSESS THE OUTCOMES OF THE CDI MODALITY INTRODUCED IN A TERTIARY REFERRAL CENTRE IN 2013. RETROSPECTIVE STUDY OF PATIENTS WITH HIGH-RISK PE TREATED BY CDI FOLLOWED BY ANTICOAGULATION BETWEEN JULY 2013 AND DECEMBER 2018. RHEOLYTIC FRAGMENTATION WAS ACHIEVED USING A 6F HYDRODYNAMIC CATHETER (ANGIOJET ULTRA PE, BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA). THE CDI PROCEDURE IN THIS INSTITUTION INCLUDES VARIOUS TECHNIQUES DEPENDING ON INDIVIDUAL CONDITIONS FOR ACCESS TO AND DISTRIBUTION OF EMBOLI IN THE PULMONARY CIRCULATION. RHEOLYTIC FRAGMENTATION, USING THE ANGIOJET SYSTEM WITH A CATHETER APPROVED FOR USE IN THE PULMONARY VESSELS, WAS APPLIED IN ALL BUT TWO PATIENTS, IN WHOM THE ROTAREX SYSTEM WAS USED. SEVERE SIDE EFFECTS OCCURRED IN ONLY 2 OF 20 PATIENTS. ONE PATIENT REACTED TO RHEOLYTIC FRAGMENTATION WITH AN EPISODE OF ASYSTOLE AND ANOTHER PATIENT DISPLAYED REPEATED BOUTS OF HYPOTENSION DUE TO FAILING RIGHT HEART PERFORMANCE. HOWEVER, BOTH CONDITIONS RESOLVED SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249880 ANGIOJET CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other