BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6517677 · Received April 25, 2017

    Report

    Report Number
    2029214-2017-00538
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    March 28, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION, THE REPORT OF CATHETER SEPARATION COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. ATTEMPTS WERE MADE TO GATHER SPECIFIC INFORMATION, HOWEVER, OUR ATTEMPTS WERE UNSUCCESSFUL. IT IS POSSIBLE THE SEPARATION OF THE MICRO CATHETER WAS DUE TO AN UNKNOWN ENTRAPMENT. ANGIOARCHITECTURE, VASOSPASM, REFLUX, LONG CATHETER DWELL TIME, ADHESIVE PROPERTIES OF SOME EMBOLIC MATERIALS, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND POTENTIAL ENTRAPMENT. PER THE OUR DEVICES INSTRUCTIONS FOR USE (IFU): ¿IF CATHETER ENTRAPMENT IS SUSPECTED (WITH ANY EMBOLIC AGENT), FAST CATHETER RETRIEVAL TECHNIQUE MAY RESULT IN CATHETER SHAFT SEPARATION AND POTENTIAL VASCULAR DAMAGE. DO NOT APPLY MORE THAN 20 CM OF TRACTION TO CATHETER TO MINIMIZE RISK OF CATHETER SEPARATION.¿ PER THE OUR DEVICES INSTRUCTIONS FOR USE (IFU): DO NOT ALLOW MORE THAN 1 CM OF THE EMBOLIC MATERIAL REFLUX BACK OVER CATHETER TIP. DIFFICULT CATHETER REMOVAL OR CATHETER ENTRAPMENT MAY BE CAUSED BY ANY OF THE FOLLOWING: ANGIOARCHITECTURE: VERY DISTAL BAVM FED BY AFFERENT, LENGTHENED, SMALL, OR TORTUOUS PEDICLES; VASOSPASM; REFLUX; INJECTION TIME. TO REDUCE THE RISK OF CATHETER ENTRAPMENT, CAREFULLY SELECT CATHETER PLACEMENT AND MANAGE REFLUX TO MINIMIZE THE FACTORS LISTED ABOVE. WHEN USING EV3 MICRO CATHETERS, DO NOT APPLY MORE THAN 20 CM OF TRACTION TO CATHETER, TO MINIMIZE RISK OF CATHETER SEPARATION.¿ LINKED EVENTS: 2029214-2017-00537 2029214-2017-00538 2029214-2017-00539 2029214-2017-00540 2029214-2017-00541.

    Description of Event or Problem · 1

    CITATION: ONYX OR COMBINED WITH OTHER EMBOLIC MATERIALS IN THE TREATMENT OF INTRACRANIAL ARTERIOVENOUS MALFORMATIONS CHEN GUANG-ZHONG' , SHU HANG, LIU MAO-CAI, ZENG SHAO-JIAN, ZHAN SHENG-QUAN, ZHOU DONG, UN XIAO-JENG, TANG KAI, ZHOU DE-XIANG, LI ZHA O-JIE, U TIE-ZIN. MEDTRONIC RECEIVE THE FOLLOWING REPORTS: 183 PATIENTS WERE TREATED. THE INTRAOPERATIVE MICROCATHETER BROKE IN 2 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302588 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability