BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MICROCATHETER

    MDR report key: 6599986 · Received May 30, 2017

    Report

    Report Number
    2029214-2017-00716
    Event Type
    Injury
    Date Received
    May 30, 2017
    Date of Event
    April 27, 2017
    Report Date
    May 4, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT BOTH A MARKSMAN 150CM AND NAVIEN 058 WERE USED DURING THE PROCEDURE. IT WAS NOT REPORTED WHICH CATHETER WAS BEING USED AT THE TIME OF ANEURYSM NECK BLEEDING. BRAND NAME: MARKSMAN CATHETER, PRODUCT CODE: KRD, MODEL NUMBER: FA-55150-1030, 510(K) NUMBER: K091559. BRAND NAME: NAVIEN INTRACRANIAL SUPPORT CATHETER, PRODUCT CODE: DQY, MODEL NUMBER: UNKNOWN, 510(K) NUMBER: K110055. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENT OCCURRED IN THE PATIENT INTRA-PROCEDURALLY AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION - ADDITIONAL INFORMATION. THE ANEURYSM NECK BLEEDING DID NOT OCCUR IN ASSOCIATION WITH ANY MEDTRONIC PRODUCTS. THERE HAVE BEEN NO ALLEGATIONS AGAINST ANY MEDTRONIC PRODUCTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT A PATIENT EXPERIENCED ANEURYSM NECK BLEEDING DURING CATHETERIZATION OF AN ANEURYSM FOR COILING. THE PATIENT SUBSEQUENTLY UNDERWENT ENDOVASCULAR COILING. THERE WERE NO REPORTS OF PATIENT SYMPTOMS IN CONNECTION WITH THIS EVENT. THE PATIENT REPORTEDLY RECOVERED WITHOUT SEQUELAE. THE PATIENT WAS UNDERGOING A PROCEDURE TO TREAT A PSEUDOANEURYSM IN A LEFT CEREBRAL ARTERY. A NAVIEN 058 GUIDE CATHETER AND MARKSMAN 150CM WERE USED DURING THE PROCEDURE. IT WAS NOT REPORTED WHICH MICROCATHETER WAS BEING USED AT THE TIME OF THE BLEED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL EVENT INFORMATION: THE ANEURYSM BLEEDING WAS DUE TO A PERFORATION BY ANOTHER MANUFACTURER'S MICROCATHETER. THE PERFORATION OCCURRED PRIOR TO USE OF ANY MEDTRONIC DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378339 UNKNOWN MICROCATHETER DQY COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention