BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE¿ HI-FLO¿ KIT

    MDR report key: 6036463 · Received October 18, 2016

    Report

    Report Number
    2134265-2016-09582
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE HUB, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. THE DEVICE WAS KINKED IN ONE PLACE APPROXIMATELY 27CM FROM THE TIP. THE CATHETER SHAFT WAS ALSO DAMAGED IN 1 PLACE, APPROXIMATELY 88 TO 90CM FROM THE TIP OF THE DEVICE. THE GUIDEWIRE WAS REMOVED FROM THE DEVICE, INSPECTED FOR DAMAGE AND REINSERTED INTO THE CATHETER. THE WIRE TRAVELED INTO THE DEVICE WITH A SLIGHT RESTRICTION. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-09581. IT WAS REPORTED THAT DIFFICULTY IN CATHETER REMOVAL OCCURRED. TWO 135/10 RENEGADE¿ HI-FLO¿ KIT WERE SELECTED FOR USE. DURING THE PROCEDURE, A GUIDEWIRE WAS ADVANCED TO THE TARGET LESION BUT HIGH RESISTANCE WAS MET DURING ADVANCEMENT OF THE CATHETER OVER THE GUIDEWIRE. THE CATHETER WAS FORCEFULLY ADVANCE AND SUCCESSFULLY REACHED THE TARGET LESION. HOWEVER, HIGH RESISTANCE WAS STILL NOTED DURING WITHDRAWAL OF THE CATHETER. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688574 RENEGADE¿ HI-FLO¿ KIT CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001183020 0017726685

    Patients

    Seq Age Sex Outcome Treatment
    1