BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 2138417 · Received June 23, 2011

    Report

    Report Number
    2134265-2011-02667
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, SURGERY WAS REQUIRED. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT CIRCUMFLEX (LCX) ARTERY. AN ICROSS CORONARY IMAGING CATHETER WAS ADVANCED ACROSS AN UNKNOWN GUIDE WIRE BUT THE IMAGING CATHETER WAS UNABLE TO CROSS THE LESION. THE WIRE AND THE ICROSS CATHETER WERE REMOVED AND THE GUIDE WIRE APPEARED AS IF IT HAD BEEN FRAYED. THE PATIENT'S LCX SHUT DOWN AND THE PATIENT WENT TO EMERGENT SURGERY. THE PATIENT IS OUT OF SURGERY AND IS IN THE INTENSIVE CARE UNIT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. IN THE PHYSICIAN'S OPINION, THE ICROSS CATHETER DID NOT CONTRIBUTE TO THE PATIENT'S NEED FOR SURGERY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAS "BAD" CORONARY DISEASE AND WAS HAVING "ISSUES" PRIOR TO THE PHYSICIAN ATTEMPTING IVUS. THE PHYSICIAN BELIEVES HE LIFTED A "FLAP" WHEN CROSSING WITH THE NON-BSC GUIDE WIRE THAT EVENTUALLY FRAYED. NO ADDITIONAL INTERVENTION WAS PERFORMED AND THE PHYSICIAN AS A GOOD PROGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICROSS 40 MHZ CORONARY IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749518050 14090833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BMW GUIDE WIRE