BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER

    MDR report key: 3135418 · Received May 29, 2013

    Report

    Report Number
    3007210311-2013-00002
    Event Type
    Other
    Date Received
    May 29, 2013
    Date of Event
    September 21, 2011
    Report Date
    September 29, 2011
    Manufacturer
    BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE OF A CTO LESION IN THE RCA IN WHICH THE CROSSBOSS CATHETER HAD BEEN USED, THE PT EXPERIENCED A DISSECTION OF THE PROXIMAL AND MID RCA WITH CONTRAST EXTRAVASATION NOTED REQUIRING A COVERED STENT, COILS AND REVERSAL OF ANTICOAGULATION TO REPAIR. THE PROCEDURE WAS ON A HIGHLY CALCIFIED AND TORTUOUS RCA, THE CROSSBOSS CATHETER WAS INTRODUCED OVER A FIELDER XT GUIDEWIRE AND PROCEEDED TO BE ADVANCED INTO THE LESION. DURING ADVANCEMENT INTO THE LESION, THE GUIDEWIRE PLACEMENT WAS LOST. THE CROSSBOSS AND FIELDER XT WERE REINTRODUCED INTO THE LESION AND ADVANCED INTO THE DISTAL VESSEL THROUGH THE LESION VIA THE TRUE LUMEN PATHWAY. THE FIELDER XT GUIDEWIRE WAS REMOVED AND REPLACED WITH A PILOT 200 GUIDEWIRE; THE CROSSBOSS CATHETER WAS THEN REMOVED AND REPLACED WITH A 2.0 X 40 APEX DILATATION BALLOON, THE BALLOON WAS INFLATED TO 12 ATMS IN PREPARATION FOR STENT PLACEMENT. UPON DEFLATION OF THE BALLOON A DISSECTION FROM THE PROXIMAL TO DISTAL RCA WITH EFFUSION WAS NOTED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH CONFIRMED THE EFFUSION. IT IS UNCLEAR THE SEQUENCE OF EVENTS REGARDING THE TREATMENT OF THE DISSECTION, IT WAS REPORTED BY (B)(4), REP WHO WAS PRESENT DURING THE PROCEDURE, THAT A GRAFTMASTER STENT WAS PLACED TO COVER THE DISSECTION, EMBOLIC COILS X 2 WERE PLACED IN A SIDE BRANCH THAT WAS FEEDING THE AREA OF THE DISSECTION AND PROTOMINE WAS GIVEN TO REVERSE ANTICOAGULATION. THE PT WAS DISCHARGE FROM THE CATH LAB TO THE ICU FOR OBSERVATION IN STABLE CONDITION. F/U REGARDING THE PT STATUS OCCURRED AT FIVE DAYS POST EVENT, IT WAS REPORTED THAT THE PT HAD BEEN DISCHARGED TO HOME IN STABLE CONDITION, NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236639 BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER CROSSBOSS DQY BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFIC M2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention