BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM PLUS¿

    MDR report key: 2143307 · Received June 29, 2011

    Report

    Report Number
    2134265-2011-02434
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE INSPECTION OF THE DEVICE REVEALED THE SPRING TIP WAS ELONGATED AND THE CORE WIRE FRACTURED AT 299.5CM FROM THE PROXIMAL END. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A TIP OF THE GUIDEWIRE DETACHED INSIDE OF THE PATIENT. THE PHYSICIAN ATTEMPTED TO TREAT A LESION IN THE PROXIMAL TIBIAL ARTERY. A PLATINUM PLUS GUIDEWIRE WAS INTRODUCED INTO THE SEVERELY CALCIFIED AND OCCLUDED SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN FELT THE TIP OF THE GUIDE WIRE GOT STUCK BETWEEN TWO VERY CALCIFIED LESIONS AND THE TIP OF THE GUIDE WIRE WAS SEPARATED INTO TWO PIECES BUT "THERE WAS A THIN LINE CONNECTED TO THE TIP". A BALLOON WAS INTRODUCED TO THE TIP OF THE TORN WIRE TO REMOVE THE GUIDE WIRE. NO FURTHER INTERVENTION WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A TIP OF THE GUIDEWIRE DETACHED INSIDE OF THE PATIENT. THE PHYSICIAN ATTEMPTED TO TREAT A LESION IN THE PROXIMAL TIBIAL ARTERY. A PLATINUM PLUS GUIDEWIRE WAS INTRODUCED INTO THE SEVERELY CALCIFIED AND OCCLUDED SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN FELT THE TIP OF THE GUIDE WIRE GOT STUCK BETWEEN TWO VERY CALCIFIED LESIONS AND THE TIP OF THE GUIDE WIRE WAS SEPARATED INTO TWO PIECES BUT "THERE WAS A THIN LINE CONNECTED TO THE TIP". A BALLOON WAS INTRODUCED TO THE TIP OF THE TORN WIRE TO REMOVE THE GUIDE WIRE. NO FURTHER INTERVENTION WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM PLUS¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001467120 13462076

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention