BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²¿

    MDR report key: 2802921 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06216
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    July 25, 2012
    Report Date
    September 25, 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

    DEVICE EVALUATED BY MFR.: THE VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS A BEND AT 181 CM AND AT 182.2 CM FROM THE PROXIMAL END, AND PTFE PEELING AROUND THE BODY. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING UNPACKING FOR A PERCUTANEOUS CORONARY INTERVENTION A GUIDEWIRE WAS KINKED. THE 185CM PT2 LIGHT SUPPORT J-TIP GUIDE WIRE WAS UNPACKED, AND IT WAS NOTED THAT THERE WAS A KINK IN THE FLEXIBLE DISTAL END OF THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED PTFE COATING WAS PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H7493893101J0

    Patients

    Seq Age Sex Outcome Treatment
    1