BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE CATHETER

    MDR report key: 12573722 · Received October 4, 2021

    Report

    Report Number
    3008264254-2021-00037
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    May 1, 2009
    Report Date
    September 9, 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). LITERATURE CITATION: LIANG G, GAO X, LI Z, WEI X, XUE H. NEUROFORM STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS: A 5 YEAR SINGLE-CENTER EXPERIENCE AND FOLLOW-UP. NEUROL RES. 2010 SEP;32(7):721-7. DOI: 10.1179/016164109X12445616596409. EPUB 2009 AUG 5. PMID: 19660196. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING LITERATURE CITATION WAS REVIEWED: LIANG G, GAO X, LI Z, WEI X, XUE H. NEUROFORM STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS: A 5 YEAR SINGLE-CENTER EXPERIENCE AND FOLLOW-UP. NEUROL RES. 2010 SEP;32(7):721-7. DOI: 10.1179/016164109X12445616596409. EPUB 2009 AUG 5. PMID: 19660196. OBJECTIVE AND METHODS: THE AUTHORS REPORT THEIR CLINICAL EXPERIENCE AND 5 YEAR FOLLOW-UP RESULTS USING NEUROFORM STENT, AS AN ADJUNCT IN THE TREATMENT OF WIDE-NECKED AND FUSIFORM ANEURYSMS. A 6F OR 8F SHEATH WAS INTRODUCED IN THE RIGHT FEMORAL ARTERY FOLLOWING A STANDARD SELDINGER PUNCTURE. A 6F OR 8F ENVOY GUIDING CATHETER WAS THEN GUIDED INTO EITHER THE CERVICAL INTERNAL CAROTID OR VERTEBRAL ARTERY, DEPENDING ON THE LOCATION OF THE ANEURYSM. THE MICROCATHETERS WERE PROWLER OR EXCELSIOR SL-10. SEQUENTIAL OR PARALLEL TECHNIQUES WERE UTILIZED. COIL MANUFACTURERS WERE NOT IDENTIFIED. PROCEDURES WERE PERFORMED ON RUPTURED AND UNRUPTURED ANEURYSMS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 6F OR 8F ENVOY GUIDING CATHETER, PROWLER MICROCATHETER OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: NEUROFORM STENT SYSTEM - WIRE & STENT(BOSTON SCIENTIFIC/TARGET), EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC/TARGET) EXACT QUANTITIES CANNOT BE DETERMINED AS THE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO DETERMINE QUANTITIES. ARTICLE DOES NOT SPECIFY WHICH MICROCATHETERS OR OTHER MEDICAL DEVICES WERE ASSOCIATED WITH THE LISTED ADVERSE EVENT(S). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 4 THROMBOEMBOLISM TREATED BY LOCAL INTRA-ARTERY ADMINISTRATION OF ABCIXIMAB AND UROKINASE AND MECHANICAL DISRUPTION OF CLOT WITH MICROWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465289 GUIDE CATHETER PERCUTANEOUS CATHETER DQY MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention