BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE CATHETER

    MDR report key: 12565974 · Received October 1, 2021

    Report

    Report Number
    3008264254-2021-00013
    Event Type
    Injury
    Date Received
    October 1, 2021
    Report Date
    September 6, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DQY
    PMA / PMN Number
    K000715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). LITERATURE CITATION: YANG HS, JOE SG, YOON YH, KIM JG. A CASE OF PURTSCHER RETINOPATHY ASSOCIATED WITH ;STENT-ASSISTED COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY ANEURYSM. EUR J OPHTHALMOL. 2013 MAR-APR;23(2):262-6. DOI: 10.5301/EJO.5000223. PMID: 23335309. 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 "A CASE OF PURTSCHER RETINOPATHY ASSOCIATED WITH STENT-ASSISTED COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY ANEURYSM" YANG, H.S., JOE, S.G., YOON, Y.H., KIM,J.G (2013) EUROPEAN JOURNAL OF OPHTHALMOLOGY, 23(2), 262-266. "OBJECTIVE AND METHODS: THIS ARTICLE REPORTS A CASE OF PURTSCHER RETINOPATHY FOLLOWING THERAPEUTIC COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. METHODS. A (B)(6) WOMAN PRESENTED TO OUR CLINIC COMPLAINING OF SEVERE HEADACHE. CEREBRAL ANGIOGRAPHY REVEALED 6.7 X 6.2 MM SACCULAR ANEURYSM IN LEFT MCA BIFURCATION. THE ANEURYSM WAS CATHETERIZED WITH GUIDING CATHETER ENVOY. 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: THE PATIENT PRESENTED POST-OPERATIVELY WITH A INTRARETINAL HEMORRHAGE MULTIPLE AREAS OF RETINAL WHITENING, WHICH RESULTED IN THE VISUAL DISTURBANCE. THE RETINAL LESIONS AND VISION DISTURBANCE RESOLVED ITSELF AFTER 5 WEEKS WITH CLOSE MONITORING. THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461032 GUIDE CATHETER PERCUTANEOUS CATHETER DQY MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other