BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 2033664 · Received March 30, 2011

    Report

    Report Number
    2134265-2011-01063
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    December 15, 2010
    Report Date
    March 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE MICROCATHETER WAS RETURNED WITH A F-IDC COIL. VISUAL AND MICROSCOPIC ANALYSIS REVEALED THE COIL AND PUSHER WIRE WERE PROTRUDING FROM THE TIP OF THE MICROCATHETER. A KINK WAS NOTED ON THE CATHETER 38CM FROM THE PROXIMAL END. THE PUSHERWIRE COULD NOT BE ADVANCED OUT OF THE MICROCATHETER. THE COIL AND DISTAL END OF THE MICROCATHETER WERE JAMMED WITHIN THE CATHETER. THE CATHETER WAS CUT TO REMOVE THE COIL AND PUSHER WIRE. AS THE COIL AND PUSHER WIRE WERE ADVANCED OUT OF THE CATHETER LUMEN BLOOD ADVANCED FROM THE CATHETER. ONCE THE PUSHER WIRE/COIL WERE REMOVED FROM THE CATHETER A FUNCTIONAL TEST WAS CARRIED OUT WITH A 0.0184IN MANDREL. THE MANDREL ADVANCED WITHOUT RESISTANCE OUT THE DISTAL END OF THE CATHETER. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER RELATED AS THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE DFU AND/OR ANY USE NOT CONSIDERED ACCEPTED GENERAL MEDICAL PRACTICE. PER DFU A MICROCATHETER WITH INNER DIAMETER OF 0.021IN IS RECOMMENDED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2011-01124. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE A COIL DETACHED AND BECAME STUCK IN THE MICROCATHETER. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. THE 135/10 0.027 RENEGADE HI-FLO MICROCATHETER WAS ADVANCED TO THE TARGET LOCATION. THREE UNSPECIFIED COILS WERE SUCCESSFULLY DEPLOYED. A 3MM X 12CM FIBERED COIL SYSTEM WAS SELECTED FOR USE AND DURING ADVANCEMENT THE COIL DETACHED AND REMAINED INSIDE THE DISTAL END OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH THE COILS THAT HAD BEEN PLACED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS UNAVAILABLE. RETURNED PRODUCT ANALYSIS REVEALED THE COIL AND PUSHER WIRE WERE PROTRUDING FROM THE TIP OF THE MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE HI-FLO MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001182880 0013247397

    Patients

    Seq Age Sex Outcome Treatment
    1