BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE? HI-FLO? FATHOM? KIT

    MDR report key: 3033233 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-02056
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K100892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION REVEALED THE RETURNED CATHETER WAS STUCK INSIDE A 5FR NON BSC DIAGNOSTIC CATHETER AND COULD NOT BE REMOVED. THE HUB OF THE CATHETER WAS BROKEN OFF. THE CATHETER SHAFT WAS BROKEN IMMEDIATELY DISTAL TO WHERE THE CATHETER EXITED THE DIAGNOSTIC CATHETER WITH 2.5CM OF BRAID EXPOSED. THE FATHOM GUIDEWIRE WAS STUCK IN THE DEVICE. DIMENSIONS THAT COULD BE MEASURED MET SPECIFICATIONS. COATING DAMAGE WAS EVIDENT PROXIMAL TO THE BREAK. THERE WAS NO PEELING OR MISSING COATING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS AN INCOMPATIBLE DIAGNOSTIC CATHETER WAS USED WITH THE DEVICE PER THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST AN EMBOLIZATION TREATMENT PROCEDURE, COATING DAMAGE OCCURRED. THE PATIENT WAS UNDERGOING TREATMENT OF UTERINE FIBROIDS. A 5FR .035" NON BSC C2 CATHETER WAS PLACED IN THE INTERNAL ILIAC ARTERY. THE RENEGADE HI FLO MICROCATHETER WAS ADVANCED, BUT BECAME STUCK APPROXIMATELY 10CM FROM THE DISTAL END OF THE DIAGNOSTIC CATHETER. THE DEVICES WERE REMOVED AND A 5FR .035" NON BSC CATHETER WITH A RIM SHAPE WAS PLACED. THE RENEGADE HI FLO BECAME STUCK AGAIN AT THE SAME LOCATION. THE PHYSICIAN DETERMINED THE POSITION OF THE RENEGADE WAS CLOSE ENOUGH AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. AFTER THE PROCEDURE, THE PHYSICIAN TRIED ADVANCING THE RENEGADE IN ONE OF THE CATHETERS WHILE OUTSIDE OF THE PATIENT AND IT AGAIN BECAME STUCK. WHEN TRYING TO PULL THE RENEGADE FROM THE DISTAL END, THE HUB DETACHED FROM THE SHAFT AND REMAINED IN THE DIAGNOSTIC CATHETER. A SHAFT KINK WAS NOTED WHERE THE MATERIAL TRANSITIONS AND THE OUTER COATING IS SPLIT AND BUNCHED UP ON THE BRAIDING AT THE LOCATION OF THE BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST AN EMBOLIZATION TREATMENT PROCEDURE, COATING DAMAGE OCCURRED. THE PATIENT WAS UNDERGOING TREATMENT OF UTERINE FIBROIDS. A 5FR .035" NON BSC C2 CATHETER WAS PLACED IN THE INTERNAL ILIAC ARTERY. THE RENEGADE HI FLO MICROCATHETER WAS ADVANCED, BUT BECAME STUCK APPROXIMATELY 10CM FROM THE DISTAL END OF THE DIAGNOSTIC CATHETER. THE DEVICES WERE REMOVED AND A 5FR .035" NON BSC CATHETER WITH A RIM SHAPE WAS PLACED. THE RENEGADE HI FLO BECAME STUCK AGAIN AT THE SAME LOCATION. THE PHYSICIAN DETERMINED THE POSITION OF THE RENEGADE WAS CLOSE ENOUGH AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. AFTER THE PROCEDURE, THE PHYSICIAN TRIED ADVANCING THE RENEGADE IN ONE OF THE CATHETERS WHILE OUTSIDE OF THE PATIENT AND IT AGAIN BECAME STUCK. WHEN TRYING TO PULL THE RENEGADE FROM THE DISTAL END, THE HUB DETACHED FROM THE SHAFT AND REMAINED IN THE DIAGNOSTIC CATHETER. A SHAFT KINK WAS NOTED WHERE THE MATERIAL TRANSITIONS AND THE OUTER COATING IS SPLIT AND BUNCHED UP ON THE BRAIDING AT THE LOCATION OF THE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136757 RENEGADE? HI-FLO? FATHOM? KIT RENEGADE HI-FLO FATHOM KIT KRA BOSTON SCIENTIFIC - CORK M001184620 15267683

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR