BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ MARKER WIRE

    MDR report key: 669729 · Received September 8, 2005

    Report

    Report Number
    6000130-2005-00424
    Event Type
    Malfunction
    Date Received
    September 8, 2005
    Date of Event
    August 10, 2005
    Report Date
    August 10, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA / STENTING TREATMENT PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTIES WHEN REMOVING THE INTERVENTIONAL BALLOON OVER THE IQ MARKER .014"/185 CM GUIDEWIRE. THE PT HAD BEEN SENT TO THE CATH LAB FOR CAROTID STENTING WHEN IT WAS NOTICED THAT SHE WAS ALSO SUFFERING FROM CORONARY ARTERY DISEASE. THE LESION BEING TREATED WAS A SIGNIFICANTLY CALCIFIED, 99% STENOTIC LESION IN THE BIFURCATION OF THE VERY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) AND 1ST DIAGONAL BRANCH (1ST DIAG) CORONARY ARTERIES. THE PHYSICIAN CHOSE TO WIRE BOTH THE LAD AND THE DIAG SO AS NOT TO LOSE THE DIAG SHOULD THERE BY ANY PLAQUE-SHIFT. FOR THE LAD HE SELECTED A PT2 GUIDEWIRE, AND FOR THE DIAGONAL, HE SELECTED THE IQ GUIDEWIRE. OVER THE PT2 GUIDEWIRE, HE INSERTED A VOYAGER BALLOON AND OVER THE IQ GUIDEWIRE HE INSERTED A MEDTRONIC SPRINTER 2.0/15 MM BALLOON. HE THEN PERFORMED A "KISSING BALLOON TECHNIQUE" IN THE BIFURCATION AND STENTED THE LAD WITH A CYPHER STENT. WHEN THE SCRUB SISTER TRIED TO REMOVE THE SPRINTER BALLOON FROM THE DIAGONAL VESSEL, THE WIRE AND BALLOON CAME OUT TOGETHER. UPON EXAMINING THE BALLOON AND WIRE OUTSIDE OF THE PATIENT'S BODY, THE PHYSICIAN CONCLUDED THAT THE NOSE CONE OF THE SPRINTER BALLOON HAD BECOME STUCK ON THE `JOINT' OF THE GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS `SATISFACTORY.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IQ MARKER WIRE PTCA GUIDEWIRE DQX BOSTON SCIENTIFIC IQ MARKER WIRE 185 CM 7468766

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR