BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 2142534 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02690
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED 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. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL WAS IMPLANTED IN AN INCORRECT LOCATION. THE TARGET LESION LOCATION WAS A FISTULA LOCATED IN THE PATIENT'S LEFT BRACHIAL VESSEL. THE 5.0MM X 8.0CM FIBERED INTERLOCK DETACHABLE COIL (F-IDC) SYSTEM WAS ADVANCED INTO A RENEGADE STC MICROCATHETER. RESISTANCE WAS MET WHILE ADVANCING THE COIL IN THE RENEGADE AND THE COIL BECAME STUCK. UNDER FLUOROSCOPY, THE PHYSICIAN WAS ABLE TO LOCATE THE COIL WITHIN THE CATHETER AND PROCEEDED TO DEPLOY THE COIL BY FLUSHING THE CATHETER WITH SALINE. HOWEVER, THE COIL DID NOT DEPLOY IN THE EXACT INTENDED LOCATION AND IT WAS DETERMINED A SECOND COIL WOULD BE NECESSARY. A SECOND 5.0MM X 8.0CM F-IDC SYSTEM WAS ADVANCED INTO THE RENEGADE CATHETER AND ALSO BECAME STUCK. THE PHYSICIAN WAS UNABLE TO DETERMINE THE LOCATION OF THIS COIL WITHIN THE CATHETER UNDER FLUOROSCOPY. HE THEN OPTED TO REMOVE THE CATHETER FROM THE PATIENT. THE CATHETER WAS FLUSHED, OUTSIDE OF THE PATIENT, AND THE COIL WAS REMOVED. THE RENEGADE CATHETER WAS THEN REINSERTED INTO THE PATIENT AND A NON BSC COIL WAS ADVANCED AND IMPLANTED IN THE ORIGINAL INTENDED LOCATION. CONTINUOUS FLUSHING WAS MAINTAINED DURING THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS 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 M001361540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RENEGADE STC MICROCATHETER