BEUDAMED
    FDA Adverse Event Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 2756538 · Received September 24, 2012

    Report

    Report Number
    2134265-2012-05737
    Date Received
    September 24, 2012
    Report Date
    August 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LIVER EMBOLISATION TREATMENT PROCEDURE, A COIL DETACHED PREMATURELY. NO RESISTANCE WAS FELT WHEN ADVANCING THE COIL THROUGH THE BSC CATHETER. RESISTANCE WAS FELT WHEN TRYING TO DEPLOY THE COIL. AFTER THE IDC WAS PLACED, IT DID NOT DEPLOY BY ITSELF SO THE PHYSICIAN TRIED TO TWIST A LITTLE TO DEPLOY IT BUT IT WAS UNSUCCESSFUL. THEN THE PHYSICIAN WITHDRAW THE DEVICE INTO THE BSC CATHETER AND THEN IT DEPLOYED IN THE PORTA VEIN WITH SOME OF THE IDC STILL LEFT OUTSIDE THE BSC CATHETER. THE PHYSICIAN USED ANOTHER DEVICE TO WITHDRAW THE IDC FROM THE PORTA VEIN. NOTHING WAS LEFT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK UNK297

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMAGER II CATHETER