BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE¿ STC 18

    MDR report key: 2833977 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06993
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    August 8, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQO
    PMA / PMN Number
    K023681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE MICROCATHETER WAS EXAMINED AND THE CATHETER WAS BROKEN AND RETURNED IN 3 PIECES. THE HUB SECTION WAS NOT RETURNED. THE MICROCATHETER WAS EXTENSIVELY STRETCHED AND DAMAGED. A MANDREL WAS INSERTED THROUGH THE 3 PIECES AND SLIGHT RESISTANCE WAS EXPERIENCED DUE TO THE DAMAGE ALONG THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST ROOT CAUSE IS CONSIDERED USER RELATED AS CONTINUOUS FLUSH DIRECTIONS IN THE RENEGADE STC MICROCATHETER DFU WERE NOT FOLLOWED. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, A SHAFT KINKED OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT THORACIC ARTERY. UTILIZING INTERMITTENT FLUSH AND A 130 MM X 30 MM RENEGADE STC 18 CATHETER, THE PHYSICIAN DEPLOYED SUCCESSFULLY THREE 4 MM X 15 MM INTERLOCK COILS. AFTER THE FOURTH COIL WAS DEPLOYED SUCCESSFULLY THE PHYSICIAN TRIED TO PULL THE WIRE BACK INTO THE RENEGADE STC BUT THE MICROCATHETER WOULD KINK UP. THE ENTIRE SYSTEM WAS PULL OUT OF THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW RENEGADE STC MICROCATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THE CATHETER WAS BROKEN IN 3 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE¿ STC 18 CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - CORK M001181320 15326436

    Patients

    Seq Age Sex Outcome Treatment
    1