BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE FIBER BRAIDED MICROCATHETER

    MDR report key: 2080696 · Received May 6, 2011

    Report

    Report Number
    2134265-2011-01562
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K020012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED THE DEVICE WAS RETURNED WITHIN THE DISPENSER HOOP. SLIGHT RESISTANCE WAS NOTED WHEN ATTEMPTING TO REMOVE THE CATHETER. THE DISPENSER HOOP WAS FLUSHED WITH SALINE AND THE CATHETER WAS THEN REMOVED WITH EASE. VISUAL AND TACTILE TESTING WERE PERFORMED ON THE CATHETER. PEELING COATING WAS NOTED ON THE CATHETER SHAFT AT 74.3CM FROM THE PROXIMAL END. THE OUTER DIAMETER OF THE DEFECT WAS 0.0535. AN APPROPRIATE SIZED MANDREL WAS ADVANCED THROUGH THE HUB WITH NO RESTRICTIONS. ALL DIMENSIONS WHICH WERE MEASURED WERE FOUND TO BE WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER ERROR AS CONTINUOUS FLUSH WAS NOT MAINTAINED AS INSTRUCTED IN THE DFU. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2011. IT WAS REPORTED THAT DURING A RESERVOIR TREATMENT PROCEDURE, THE MICROCATHETER WOULD NOT INSERT INTO THE SHEATH. THE INTENDED TARGET LOCATION WAS THE LIVER. A 5FR NON BSC INTRODUCER SHEATH WAS PLACED. THE RENEGADE MICROCATHETER WAS ATTEMPTED TO BE INSERTED INTO THE SHEATH, BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME RENEGADE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THE COATING OF THE MICROCATHETER HAD PEELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE FIBER BRAIDED MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001182520 13848718

    Patients

    Seq Age Sex Outcome Treatment
    1 5FR MEDIKIT INTRODUCER SHEATH| 0.014" TRANSEND GUIDEWIRE