BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 1551387 · Received December 1, 2009

    Report

    Report Number
    2939204-2009-00878
    Event Type
    Injury
    Date Received
    December 1, 2009
    Date of Event
    September 8, 2009
    Report Date
    November 2, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE MFR AND EXP DATES CANNOT BE DETERMINED. IN REVIEW OF THE PROCEDURE SUMMARY, IT WAS NOTED THAT NITROGLYCERIN IC (NTG) WAS ADMINISTERED AFTER IVUS INSERTION. THE DFU RECOMMENDS NTG ADMINISTRATION PRIOR TO IVUS INSERTION INTO THE CORONARY VASCULAR BED. THE DEVICE WAS DISPOSED BY THE FACILITY; THEREFORE, A DEVICE EVAL CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT ENROLLED IN A CLINICAL TRIAL FOR THE TREATMENT OF DE NOVO CORONARY ARTERY LESIONS HAD UNDERGONE A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT AN 80% STENOTIC LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE TARGET LESION WAS PRE-DILATED WITH A BALLOON FOLLOWED BY THE DEPLOYMENT OF A DRUG ELUTING STENT. POST PTCA AND STENT PLACEMENT, INTRAVASCULAR ULTRASOUND (IVUS) IMAGING IDENTIFIED GOOD STENT APPOSITION, HOWEVER, A VESSEL OCCLUSION WAS NOTED IN THE MID-DISTAL LAD. AFTER A SECOND BALLOON DILATION, NORMAL FLOW WAS IMMEDIATELY ACHIEVED. FOLLOWING THE INTERVENTION, THERE WAS NO INJURY.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention GUIDE CATHETER: MEDTRONIC 6F SHERPA| STENT: MFR UNK| BALLOON CATHETER: BSC APEX MONORAIL| GUIDE WIRE: ABBOTT BMW