BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 3163335 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-04098
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    November 10, 2012
    Report Date
    May 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE: ANTONELLA DE ROSA, DHANWANT GOMEZ, JOHN G POLLOCK, PETER BUNGAY, MARIO DE NUNZIO, RICHARD I HALL, PETER THURLEY; THE RADIOLOGICAL MANAGEMENT OF PSEUDOANEURYSMS COMPLICATING PANCREATITIS; JOP. J PANCREAS (ONLINE) 2012 NOV 10; 13(6):660-666. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT POST AN EMBOLIZATION TREATMENT PROCEDURE, COIL MIGRATION OCCURRED. THE PATIENT UNDERWENT TREATMENT OF A PSEUDOANEURYSM ASSOCIATED WITH PANCREATITIS. EMBOLIZATION WAS PERFORMED WITH UNSPECIFIED .035¿ OR .018¿ FIBERED COILS. AT AN UNSPECIFIED TIME FOLLOWING EMBOLIZATION, COIL MIGRATION FROM THE SPLENIC ARTERY TO A BRANCH OF THE RIGHT HEPATIC ARTERY WAS OBSERVED. THE COIL WAS LEFT IN-SITU AS THERE WAS NO EVIDENCE OF THROMBOSIS OF THE OTHER HEPATIC ARTERY BRANCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264489 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK UNK297

    Patients

    Seq Age Sex Outcome Treatment
    1 Other