BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VASCULAR PLUG

    MDR report key: 4808891 · Received June 1, 2015

    Report

    Report Number
    2029214-2015-00594
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    April 8, 2014
    Report Date
    April 10, 2014
    Manufacturer
    REVERSE MEDICAL CORP/COVIDIEN
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MODEL NUMBER OR LOT NUMBER WAS REPORTED FOR THE DEVICE. THE PRODUCT WAS NOT RETURNED BACK TO REVERSE MEDICAL CORP. THE MICRO VASCULAR PLUG REMAINS IMPLANTED WITHIN THE PATIENT. THE USER USED THE DEVICE FOR TEMPORARY OCCLUSION WHICH THE DEVICE IS NOT INDICATED FOR. THE DEVICE WAS USED WITH EMBOLIZATION PARTICLES AND GLUE WHICH IT IS NOT INDICATED FOR. THE PHYSICIAN BELIEVES THAT IT WAS USER ERROR. THE USER USED THE MICRO VASCULAR PLUG IN A MANNER WHICH WAS NOT CONSISTENT WITH THE INDICATIONS FOR USE.

    Description of Event or Problem · 1

    MEDTRONIC COVIDIEN/REVERSE MEDICAL CORP RECEIVED INFORMATION THAT DURING A BRAIN ARTERIOVENOUS MALFORMATION EMBOLIZATION TREATMENT, THE PHYSICIAN REPORTED THAT THE MVP GOT DETACHED UNINTENTIONALLY. THE PHYSICIAN OPENED AN MVP ON THE VENOUS SIDE TO STOP THE FLOW AND TO ENABLE THE PHYSICIAN TO INJECT EMBOLIZATION PARTICLES ON THE ARTERIAL SIDE. THE PROCEDURE WENT AS PLANNED. THE PHYSICIAN ALSO INJECTED SOME GLUE TO COMPLETE THE EMBOLIZATION PROCEDURE. AT THE MOMENT OF RETRIEVING THE MVP, IT GOT DETACHED. IT HAD REMAINED OPEN IN THE VEIN FOR ABOUT 1 HOUR. THE PHYSICIAN SUGGESTED THAT THE DETACHMENT POINT GOT WEAKENED BY BEING LEFT FOR A LONG TIME IN THE BLOOD VESSEL. IT WAS REPORTED THAT INSTEAD OF RESHEATHING THE MVP BY PUSHING THE MICROCATHETER OVER THE PLUG, THE PHYSICIAN PULLED ON THE PLUG. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353502 MICRO VASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD REVERSE MEDICAL CORP/COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1