BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER

    MDR report key: 2593841 · Received May 29, 2012

    Report

    Report Number
    3007210311-2012-00003
    Event Type
    Other
    Date Received
    May 29, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 24, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K081130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN EFFORT TO UNDERSTAND AND ACCURATELY CHARACTERIZE BRIDGEPORT MEDICAL DEVICE INVOLVEMENT, BRIDGEPOINT MEDICAL SR. CLINICAL SCIENCE SPECIALIST CONTACTED DR. (B)(6) ON (B)(4) 2012, HE STATED THAT HE IS UNCERTAIN IF THE BRIDGEPORT DEVICE EXITED THE ARTERY BECAUSE OF THE ACUTE BEND HE WAS TRYING TO MANEUVER AROUND OR IF IT FOLLOWED THE TRACK OF THE GUIDEWIRE WHERE THERE HAD BEEN A WIRE PERFORATION JUST A FEW MINS PRIOR WITH NO CONTRAST EXTRAVASATION. DR. (B)(6) CONFIRMED THAT THE PT IS PAIN FREE, ALL TESTS PERFORMED (ECHO, EKG, CK ISOENZYMES) WERE EITHER NORMAL OR NEGATIVE AND THAT THE PT HAS SUFFERED NO ADVERSE EFFECTS FROM THE EPISODE.

    Description of Event or Problem · 1

    A PERFORATION TO THE MID LAD CORONARY ARTERY OCCURRED DURING A PROCEDURE TO REOPEN A CTO LESION IN THE LAD. INITIALLY AN UNSUCCESSFUL ATTEMPT TO CROSS THE LESION WAS PERFORMED WITH AN 0.014" GUIDEWIRE LOADED IN A 1.5 BALLOON CATHETER, THE BALLOON CATHETER WAS REMOVED AND THE CROSSBOSS CATHETER WAS INSERTED. IN AN ATTEMPT TO SPIN THE CROSSBOSS AROUND A SHARP BEND IN THE ARTERY IS WHEN THE PERFORATION WAS NOTED. DR. (B)(6) STATES THAT HE IS UNCERTAIN IF THE CROSSBOSS EXITED THE ARTERY BECAUSE OF THE ACUTE BEND OR IF IT FOLLOWED THE TRACK OF THE GUIDEWIRE WHERE THERE HAD BEEN A WIRE PERFORATION JUST A FEW MINS BEFORE WITH NO CONTRAST EXTRAVASATION. THE PT DID COMPLAIN OF CHEST PAIN AT THE TIME BUT THIS WAS RELIEVED WHEN A BALLOON CATHETER WAS PLACED JUST PROXIMAL TO THE PERFORATION AND THE BALLOON WAS INFLATED (TOTAL ATM NOT REPORTED). THE HEPARIN WAS REVERSED WITH PROTOMINE AND THE PERFORATION WAS TREATED WITH BALLOON TAMPONADE. ECHOCARDIOGRAM PERFORMED IN THE CATH LAB AT THE TIME OF THE ADVERSE EPISODE SHOWED NO EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER CROSSBOSS DQY BRIDGEPOINT MEDICAL INC. M2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention