BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IQ GUIDE WIRE

    MDR report key: 1982651 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00252
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K040140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A GUIDE WIRE FRACTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND NON-TORTUOUS AND RIGHT CORONARY ARTERY. AS THE PHYSICIAN ADVANCED THE 185CM IQ STRAIGHT TIP GUIDE WIRE ACROSS THE LESION, RESISTANCE WAS NOTED AND THE WIRE COULD NOT BE ADVANCED BEYOND THE LESION. THE PHYSICIAN DECIDED TO EXCHANGE IQ GUIDE WIRE, HOWEVER, DURING AN ATTEMPT TO WITHDRAW THE GUIDE WIRE, RESISTANCE WAS ENCOUNTERED AND IT WAS NOTED THAT THE IQ GUIDE WIRE WAS STUCK IN THE LESION. THE PHYSICIAN PULLED HARD ON THE IQ GUIDE WIRE AND THE DISTAL 5CM OF DETACHED AND REMAINED ACROSS THE DISTAL RCA LESION. NO ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED GUIDE WIRE FRAGMENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THIS DEVICE. 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 IQ GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74938950010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other