BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 1702555 · Received May 28, 2010

    Report

    Report Number
    2939204-2010-00701
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISPOSED BY THE FACILITY; THEREFORE, PRODUCT INSPECTION COULD NOT BE PERFORMED. WHILE THE LOT NUMBER WAS UNKNOWN, A SHIP HISTORY WAS PERFORMED FOR THE MONTH PRIOR TO THE DATE OF THE PROCEDURE; THREE PROBABLE LOTS WERE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED ON THE IDENTIFIED LOTS AND NO ISSUES OR DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ADDITIONALLY, NO SIMILAR COMPLAINTS BY EVENT DESCRIPTION WERE FOUND IN THESE LOTS. THE DEVICE LABELING AND DFU WERE REVIEWED AND REVEALED THAT THE LABELING AND/OR DFU CONTAINS THESE WARNINGS AND PRECAUTIONS: WARNINGS: " NEVER ADVANCE OR WITHDRAW THE IMAGING CATHETER WITHOUT FLUOROSCOPIC VISUALIZATION BECAUSE IT MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. "DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS. A CATHETER THAT IS FORCIBLY ADVANCED MAY CAUSE CATHETER DAMAGE RESULTING IN VESSEL INJURY OR PATIENT COMPLICATIONS." PRECAUTIONS: "NEVER ADVANCE THE DISTAL TIP OF THE IMAGING CATHETER NEAR THE VERY FLOPPY END OF THE GUIDEWIRE. THIS PART OF THE GUIDEWIRE WILL NOT ADEQUATELY SUPPORT THE CATHETER. A CATHETER ADVANCED TO THIS POSITION MAY NOT FOLLOW THE GUIDEWIRE WHEN IT IS RETRACTED AND CAUSE THE GUIDEWIRE TO BUCKLE INTO A LOOP WHICH THE CATHETER MAY DRAG ALONG THE INSIDE OF THE VESSEL AND CATCH ON THE GUIDE CATHETER TIP. IF THIS OCCURS, IT WILL BE NECESSARY TO REMOVE THE CATHETER ASSEMBLY, GUIDEWIRE AND THE GUIDE CATHETER TOGETHER. IF THE CATHETER IS ADVANCED TOO NEAR THE END OF THE GUIDEWIRE, ADVANCE THE GUIDEWIRE WHILE HOLDING THE IMAGING CATHETER STEADY. IF THIS FAILS, WITHDRAW THE CATHETER AND GUIDEWIRE TOGETHER." BASED ON THE INFORMATION, IT APPEARS THAT THE SUBJECT DEVICE WAS ADVANCED TOO FAR DISTALLY ON THE GUIDEWIRE, EVENTUALLY COMING OUT OF THE GUIDEWIRE EXIT PORT (MONORAIL); THIS IS AGAINST THE DEVICE DFU WARNINGS AND PRECAUTIONS. INFORMATION FROM THE SALES REPRESENTATIVE AND PHYSICIAN REPORTED THAT A DISSECTION RESULTED, AND THAT IT WAS DUE TO OPERATOR ERROR (PER EVENT: "...THE PHYSICIAN PUSHED IT TO FAR CAUSING A DISSECTION."). THERE IS NOT ENOUGH INFORMATION TO DEFINITIVELY DETERMINE WHICH DEVICE OR DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IT SHOULD BE NOTED THAT THERE IS NO APPARENT DEVICE MALFUNCTION; THEREFORE, A PROBABLE ROOT CAUSE OF USER/USE ERROR WAS ASSIGNED TO THIS COMPLAINT FOR THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO OBTAIN THE LOT NUMBER OF THE DEVICE AND THE DEVICE HAS BEEN DISPOSED OF BY THE FACILITY, THEREFORE DHR REVIEW AND DEVICE ANALYSIS WILL NOT BE PERFORMED.

    Description of Event or Problem · 1

    WHILE ADVANCING THE INTRAVASCULAR ULTRASOUND IMAGING CATHETER (IVUS) THE PHYSICIAN PUSHED IT TO FAR CAUSING THE GUIDEWIRE TO COME OUT OF THE SHORT MONORAIL OF THE CATHETER (GUIDEWIRE EXIT PORT). AS A RESULT A DISSECTION OCCURRED. PHYSICIAN WAS NOT SURE IF THE GUIDEWIRE OR THE IMAGING CATHETER CAUSED THE DISSECTION, WHICH WAS TREATED WITH A STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Description of Event or Problem · 1

    WHILE ADVANCING THE INTRAVASCULAR ULTRASOUND IMAGING CATHETER (IVUS) THE PHYSICIAN PUSHED IT TO FAR CAUSING THE GUIDEWIRE TO COME OUT OF THE SHORT MONORAIL OF THE CATHETER (GUIDEWIRE EXIT PORT). AS A RESULT A DISSECTION OCCURRED. PHYSICIAN WAS NOT SURE IF THE GUIDEWIRE OR THE IMAGING CATHETER CAUSED THE DISSECTION, WHICH WAS TREATED WITH A STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 014 BMW WIRE: ABBOTT