BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCATHETER

    MDR report key: 6450626 · Received March 31, 2017

    Report

    Report Number
    2029214-2017-00334
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    April 6, 2012
    Report Date
    November 16, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ATTEMPTS HAVE BEEN MADE TO OBTAIN SPECIFIC INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UN SUCCESSFUL. VASCULAR THROMBOSIS IS A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. MDR RELATED TO THIS EVENT: 2029214-2017-00333, 2029214-2017-00334, 2029214-2017-00335, 2029214-2017-00336, 2029214-2017-00337, 2029214-2017-00338, 2029214-2017-00339, 2029214-2017-00340, 2029214-2017-00341. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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

    CITATION: ONYX VERSUS N-BCA FOR EMBOLIZATION OF CRANIAL DURAL ARTERIOVENOUS FISTULAS. RABINOV JD1, YOO AJ, OGILVY CS, CARTER BS, HIR SCH JA. J NEUROINTERV SURG. 2013 JUL;5(4):306-10. DOI: 10.1136/NEURINTSURG-2011-010237. EPUB 2012 MAY 1. MEDTRONIC RECEIVED THE FOLLOWING REPORT: PATIENT 11 (FEMALE, AGE RANGE 50-59 YEARS) DEVELOPED A CLOT IN THE EXTERNAL CAROTID ARTERY DURING MICROCATHETER NAVIGATION IN THE SECOND EMBOLIZATION, HOWEVER, THE PATIENT WAS ASYMPTOMATIC. THERE WAS NO REPORT OF ADDITIONAL MEDICAL INTERVENTION BEING GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233321 MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other