BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 2143401 · Received June 29, 2011

    Report

    Report Number
    2134265-2011-02422
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH NO OTHER DEVICES. THE HIGH TORQUE SLEEVE (HTS) WAS FRACTURED IN THREE LOCATIONS 5.75CM, 5.90CM, AND 6CM FROM THE TIP. THE CORE WIRE WAS INTACT. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, GUIDE WIRE REMOVAL DIFFICULTIES AND A GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE PROXIMAL RCA WAS 6MM IN DIAMETER. NO LESIONS WERE IDENTIFIED IN THE PROXIMAL RCA. THE PHYSICIAN INSERTED THIS 185CM KINETIX GUIDE WIRE THROUGH ANOTHER MANUFACTURERS' 6F INTRODUCER SHEATH AND ADVANCED. DURING ADVANCEMENT, THE KINETIX GUIDE WIRE WENT INTO A SIDE BRANCH PROXIMAL TO THE LESION. THE PHYSICIAN ATTEMPTED TO PULL BACK ON THE GUIDE WIRE; HOWEVER, THE WIRE WAS STUCK IN THIS SIDE BRANCH. THE PHYSICIAN THEN PULLED BACK WITH MORE FORCE, AT THIS TIME IT WAS NOTED THE WIRE WOULD PULL BACK AN INCH OR SO BUT THE TIP OF THE WIRE DID NOT APPEAR TO MOVE INDICATING THAT A WIRE FRACTURE HAD OCCURRED. A CUTDOWN ON THE PATIENTS' GROIN WAS PERFORMED BY A VASCULAR SURGEON TO REMOVE THE GUIDE WIRE. NO PART OF THE GUIDE WIRE DETACHED OR WAS LEFT INSIDE THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F TERUMO INTRODUCER SHEATH