BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE¿ HI-FLO¿ FATHOM¿ KIT

    MDR report key: 2032041 · Received March 28, 2011

    Report

    Report Number
    2134265-2011-00860
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K100892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETURNED DEVICE CONSISTED OF A GUIDE WIRE; THE MICROCATHETER WAS NOT RETURNED. THE DEVICE WAS EXAMINED AND NO FOREIGN MATTER COULD BE FOUND ON THE GUIDEWIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CHEMOTHERAPY EMBOLIZATION TREATMENT PROCEDURE, THE DEVICE WAS CONTAMINATED. AS THE PHYSICIAN UNPACKED THE FATHOM 16 180CM RENEGADE HI FLO 135CM 20 KIT IT WAS NOTED THAT THE DISTAL END OF THE FATHOM GUIDE WIRE WAS COVERED WITH 'SMALL DEBRIS' THAT WAS STICKY TO THE TOUCH'. IT WAS ALSO NOTED THAT THE OUTER PACKAGING AND THE STERILE POUCH WERE NOT DAMAGED. THE DEVICE WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CHEMOTHERAPY EMBOLIZATION TREATMENT PROCEDURE, THE DEVICE WAS CONTAMINATED. AS THE PHYSICIAN UNPACKED THE FATHOM 16 180CM RENEGADE HI FLO 135CM 20 KIT IT WAS NOTED THAT THE DISTAL END OF THE FATHOM GUIDE WIRE WAS COVERED WITH 'SMALL DEBRIS' THAT WAS STICKY TO THE TOUCH¿. IT WAS ALSO NOTED THAT THE OUTER PACKAGING AND THE STERILE POUCH WERE NOT DAMAGED. THE DEVICE WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE¿ HI-FLO¿ FATHOM¿ KIT RENEGADE HI-FLO FATHOM KIT KRA BOSTON SCIENTIFIC - CORK M001184630 13434374

    Patients

    Seq Age Sex Outcome Treatment
    1