BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²¿

    MDR report key: 2774287 · Received October 5, 2012

    Report

    Report Number
    2134265-2012-06086
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    July 17, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED, IT WAS OBSERVED THAT THE DISTAL PART OF THE WIRE IS FRACTURED AT 183.2 CM FROM THE PROXIMAL END, ADDITIONALLY THE DISTAL END IS BENT IN THE LAST 2 CM. THE PROXIMAL END OF THE WIRE IS KINKED AT 0.7 CM FROM THE PROXIMAL END. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS TO DETERMINE THE FRACTURE FAILURE MODE. THE EXTERNAL LAB RETURNED THE FOLLOWING RESULTS: FAILURE OCCURRED DUE TO A FATIGUE EVENT FOLLOWED BY A TENSION OVERLOAD. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS REPORTABLE BASED ON THE PRELIMINARY ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE THE GUIDE WIRE WAS KINKED. THE 185CM PT² J TIP GUIDE WIRE WAS BEING UNPACKED WHEN IT WAS NOTED THAT THE TIP WAS KINKED AND NEARLY BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE DISTAL END OF THE WIRE IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H7493893101J2 001510587310

    Patients

    Seq Age Sex Outcome Treatment
    1