BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE CATHETER

    MDR report key: 12573825 · Received October 4, 2021

    Report

    Report Number
    3008264254-2021-00039
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    August 1, 2018
    Report Date
    September 10, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DQY
    PMA / PMN Number
    K000715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) UNDER MRN 3008264254-2021-00039 IS BEING RETRACTED. THE REPORT WAS SUBMITTED IN ERROR. RETRACTION OF INITIAL REPORT (B)(4) UNDER MRN 3008264254-2021-00039.

    Additional Manufacturer Narrative · 0

    (B)(4). LITERATURE ARTICLE CITATION: "COMPARISON OF MICRO-CLAMPING STENT-RETRIEVER THROMBECTOMY WITH CONVENTIONAL STENT-RETRIEVER THROMBECTOMY IN INTRACRANIAL LARGE VESSEL EMBOLISM" REVIEWED. LIU, Z. S., DENG, G., ZHOU, L. J., SUN, Y., ZHANG, X. J., KUANG, X. W., QIN, Y. L., WANG, J. X., & SHAN, Q. (2018). WORLD NEUROSURGERY , 116 , E662¿E669. HTTPS://DOI.ORG/10.1016/J.WNEU.2018.05.066 DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    LITERATURE ARTICLE "COMPARISON OF MICRO-CLAMPING STENT-RETRIEVER THROMBECTOMY WITH CONVENTIONAL STENT-RETRIEVER THROMBECTOMY IN INTRACRANIAL LARGE VESSEL EMBOLISM" REVIEWED. LIU, Z. S., DENG, G., ZHOU, L. J., SUN, Y., ZHANG, X. J., KUANG, X. W., QIN, Y. L., WANG, J. X., & SHAN, Q. (2018). WORLD NEUROSURGERY , 116 , E662¿E669. HTTPS://DOI.ORG/10.1016/J.WNEU.2018.05.066 OBJECTIVE AND METHODS: TO EVALUATE THE EFFECTIVENESS OF MICROCLAMPING STENT-RETRIEVER THROMBECTOMY (MSRT) IN PATIENTS WITH ACUTE ISCHEMIC STROKE WITH INTRACRANIAL LARGE VESSEL EMBOLISM (ILVE), AND COMPARE IT WITH THAT OF CONVENTIONAL STENT-RETRIEVER THROMBECTOMY (CSRT). WE RETROSPECTIVELY EVALUATED 108 PATIENTS WITH ILVA TREATED BY MSRT (N [ 52) OR CSRT (N [ 56) FROM THE 2 PARTICIPATING INSTITUTIONS BETWEEN JANUARY 2016 AND NOVEMBER 2017. THE RATES OF SUCCESSFUL (MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION [MTICI] GRADE 2B OR 3) AND COMPLETE REPERFUSION (MTICI GRADE 3), TIME FROM GUIDE CATHETER PLACEMENT TO REPERFUSION, RATES OF FIRST-PASS SUCCESS, AND THE NUMBER OF PASSES FOR REPERFUSION WERE COMPARED BETWEEN THE MSRT AND CSRT GROUPS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENVOY CATHETER OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: 11 PATIENTS EXPERIENCED SUBARACHNOID HEMORRHAGE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471482 GUIDE CATHETER PERCUTANEOUS CATHETER DQY MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening