BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 2162689 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-03109
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABDOMINAL AORTIC ANEURYSM TREATMENT PROCEDURE, A MISSING COIL WAS NOTED. THE ANATOMICAL LOCATION FOR TREATMENT WAS THE LUMBAR ARTERY. A 2D 3MM X 6CM INTERLOCK DETACHABLE COIL WAS SELECTED FOR USE. HOWEVER, AFTER THE COIL WAS LOADED AND ADVANCED WITH THE COIL PUSHER IT WAS NOTED THAT THE COIL WAS NOT AT THE END OF THE PUSHER. THE PHYSICIAN LOOKED ALONG THE LENGTH OF THE MICRO CATHETER, THE EMBOLIZATION SITE, IN THE SHEATH AND IN THE DISTAL VESSELS; HOWEVER, NO COIL WAS LOCATED. THE PHYSICIAN BELIEVES THE COIL WAS NEVER LOADED ONTO THE END OF THE COIL PUSHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    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 M001361500 14337613

    Patients

    Seq Age Sex Outcome Treatment
    1