BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANT COBALT

    MDR report key: 3811461 · Received May 15, 2014

    Report

    Report Number
    9612164-2014-00514
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-DETACHMENT OF A COMPONENT OF THE SYSTEM - RELATED TO ANOTHER DRUG/DEVICE -HEMOSTATIC VALVE/SHEATH. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. NO DEVICE RECEIVED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATTEMPT TO TREAT A LESION IN THE ILIAC ARTERY, THE PHYSICIAN NOTED THE STENT DISLODGED FROM BALLOON INSIDE THE SHEATH. THE DEVICE WAS PREPPED, INSPECTED AND REMOVED FROM PACKAGING AS PER IFU WITH NO ISSUES NOTED. THE STENT DISLODGEMENT OCCURRED DURING INSERTION INTO HOMEOSTATIC VALVE. THE PHYSICIAN REMOVED SHEATH AND DISCARDED THE STENT. THE STENT WAS NOT IMPLANTED IN PATIENT. NO PATIENT INJURY OR CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292029 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND 0006779433

    Patients

    Seq Age Sex Outcome Treatment
    1