BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL GUIDEWIRE WI/FLOPPY PLATINUM

    MDR report key: 1812573 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03706
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    DYB
    PMA / PMN Number
    K952828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THERE WAS NO RESIDUE PRESENT ON THE DEVICE INDICATING THAT DEVICE WAS NOT USED BY CUSTOMER. THE POUCH WAS OPENED TO OBSERVE THE GUIDEWIRE ASSEMBLY. UPON EVALUATION, THE GUIDEWIRE WAS FOUND LOADED CORRECTLY INSIDE THE HOOP ASSEMBLY. NO DAMAGES WERE OBSERVED ON THE GUIDEWIRE ASSEMBLY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE DESIGN RELATED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-03649, 2134265-2010-03708, 2134265-2010-03707. IT WAS REPORTED THAT DURING PLACEMENT OF AN ABSCESS DRAINAGE CATHETER FOR A LIVER ABSCESS, A PERFORATION OCCURRED. AN F/G 0.018 PLATINUM NITINOL GUIDE WIRE WAS BEING USED. THE PHYSICIAN STATED HE LOADED THE GUIDE WIRE WITH THE PROXIMAL END FIRST DUE TO HOW THE GUIDE WIRE IS LOADED IN THE PACKAGING HOOP THE TIP OF THE GUIDE WIRE CAUSED A PERFORATION OF THE LIVER HILUS. THE PHYSICIAN THEN PULLED THREE ADDITIONAL PLATINUM NITINOL GUIDE WIRES AND CONFIRMED THEY WERE PACKAGED THE SAME. THESE GUIDE WIRES WERE NOT USED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS HOSPITALIZED AND REPORTED AS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-03649, 2134265-2010-03708, 2134265-2010-03707. IT WAS REPORTED THAT DURING PLACEMENT OF AN ABSCESS DRAINAGE CATHETER FOR A LIVER ABSCESS, A PERFORATION OCCURRED. AN F/G 0.018 PLATINUM NITINOL GUIDE WIRE WAS BEING USED. THE PHYSICIAN STATED HE LOADED THE GUIDE WIRE WITH THE PROXIMAL END FIRST DUE TO HOW THE GUIDE WIRE IS LOADED IN THE PACKAGING HOOP THE TIP OF THE GUIDE WIRE CAUSED A PERFORATION OF THE LIVER HILUS. THE PHYSICIAN THEN PULLED THREE ADDITIONAL PLATINUM NITINOL GUIDE WIRES AND CONFIRMED THEY WERE PACKAGED THE SAME. THESE GUIDE WIRES WERE NOT USED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS HOSPITALIZED AND REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITINOL GUIDEWIRE WI/FLOPPY PLATINUM INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - SPENCER M001207110 13291084

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR