BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 1951361 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05823
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED THE CATHETER WAS RECEIVED IN TWO SECTIONS. THE LOCATION OF THE BREAK WAS 56.5CM FROM THE PROXIMAL END. THE PROXIMAL SECTION HAD SHAFT KINKS AT 32.3 AND 52.3CM FROM THE HUB. THE DISTAL SECTION WAS KINKED AT 9.3, 17 AND 22.6CM FROM THE TIP. AN APPROPRIATE SIZED MANDREL WAS ADVANCED THROUGH THE PROXIMAL PORTION AND RESTRICTION WAS EXPERIENCED AT THE KINKS, BUT THE MANDREL ADVANCED OUT THE PROXIMAL END. THE MANDREL WAS ADVANCED THROUGH THE DISTAL TIP WITH RESTRICTION AT THE NOTED KINKS AND BLOOD WAS ADVANCED OUT OF THE MICRO CATHETER. DIMENSIONAL MEASUREMENTS WHICH WERE ABLE TO BE TAKEN WERE FOUND TO MEET SPECIFICATIONS. SEM ANALYSIS CONCLUDED THAT THE APPEARANCE OF THE BREAK IS CONSISTENT WITH THE DISTAL PORTION OF THE CATHETER BEING SOMEHOW LOCKED INTO THE DELIVERY SHEATH WITH SUBSEQUENT TWISTING BACK AND FORTH OF THE HIFLO CATHETER TO CAUSE THE OUTER PEBAX INTER LAYER CO-EXTRUSION (ILC) TO BE DAMAGED WITH SUBSEQUENT FRAYING/BREAKAGE OF THE LIQUID CRYSTAL POLYMER (LCP) BRAID. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATOCELLULAR CARCINOMA TREATMENT PROCEDURE, THE CATHETER SHAFT WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS S5 OF THE LIVER. A NON BSC 5FR GUIDE CATHETER WAS PLACED IN THE PATIENT. INTERMITTENT FLUSHING WAS MAINTAINED. THE 135/20 RENEGADE HI FLO MICROCATHETER BROKE 15CM FROM THE DISTAL END WHILE IN THE GUIDE CATHETER. THE RENEGADE WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A .016" GUIDE WIRE HAD BEEN INSERTED INTO THE RENEGADE HI-FLO MICROCATHETER PRIOR TO THE SHAFT BREAK. THE BREAK WAS COMPLETE AND IT OCCURRED WHILE ADVANCING THE RENEGADE THROUGH THE GUIDE CATHETER; HOWEVER, THERE WAS NOT ANY RESISTANCE NOTED BETWEEN THE TWO DEVICES. IT IS UNKNOWN IF THE RENEGADE HAD BEEN USED IN THE PROCEDURE PRIOR TO THIS OR IF THIS WAS THE FIRST TIME THE RENEGADE WAS ADVANCED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE HI-FLO MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001182890 13247394

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDIKIT 5FR GUIDE CATHETER