BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 1378758 · Received May 8, 2009

    Report

    Report Number
    2939204-2009-00389
    Event Type
    Injury
    Date Received
    May 8, 2009
    Date of Event
    April 9, 2009
    Report Date
    April 9, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER) -NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. THE DEVICE WAS DISPOSED BY THE FACILITY; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    THE CIRCUMFLEX (CX) WAS ACCESSED AND A GUIDE CATHETER AND GUIDEWIRE WERE PLACED. AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO IMAGE THE CX. AN UNSUCCESSFUL ATTEMPT WAS MADE TO CROSS INTO A CALCIFIED, NON-TORTUOUS LEFT ANTERIOR DESCENDING (LAD) LESION WITH THIS IVUS CATHETER. THE PHYSICIAN ASKED FOR A DIFFERENT TYPE OF IVUS CATHETER, WHICH WAS USED TO SUCCESSFULLY IMAGE THE LAD. A BALLOON CATHETER WAS INFLATED A FEW TIMES AND THEN REMOVED. A STENT WAS DEPLOYED, THE DELIVERY SYSTEM REMOVED AND POST IVUS WAS THEN PERFORMED. UPON WITHDRAWAL OF THE IVUS CATHETER, THE PHYSICIAN NOTICED A DISSECTION IN THE MID-LAD HAD OCCURRED. IT WAS REPORTED THAT THE PT'S BLOOD FLOW HAD DECREASED AFTER THE STENT PLACEMENT AND WAS NON-EXISTENT AFTER IVUS. THE PT HAD SEVERE CHEST PAIN AND ST ELEVATION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. VARIOUS ATTEMPTS WERE MADE TO REPAIR THE DISSECTION, BUT NOTHING HELPED. THE PT WAS SENT FOR EMERGENT BYPASS SURGERY. THE PT'S CURRENT CONDITION IS UNK. SAME EVENT AS MFR. REPORT#: 2134265-2009-02104 FILED FOR THE BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICROSS 40 MHZ CORONARY IMAGING CATHETER CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFIC CORP. H749518050 12111150

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention BALLOON CATHETER: APEX 3.0X12MM| GUIDE WIRE: BMW| GUIDE CATHETER: 6F JL4| STENT: PROMUS 3.0X18MM