BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER

    MDR report key: 3224752 · Received July 12, 2013

    Report

    Report Number
    3007210311-2013-00004
    Event Type
    Other
    Date Received
    July 12, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFC
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO (B)(4), FIELD CLINICAL SPECIALIST FOR BOSTON SCIENTIFIC, WHO WAS PRESENT AT THE PROCEDURE, THAT THE PATIENT HAD REMAINED STABLE POST-PROCEDURE AND OVERNIGHT.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON A LCX CTO LESION, THE PATIENT SUFFERED A DISSECTION IN THE DISTAL VESSEL, BECAME HEMODYNAMICALLY UNSTABLE AND REQUIRED ACLS PROTOCOL. THE PROCEDURE WAS ON A CALCIFIED LCX CTO LESION AND THAT THE CROSSBOSS CATHETER DID TRACK PAST THE LESION VIA THE TRUE LUMEN WITH SOME DIFFICULTY, EMPLOYING NUMEROUS GUIDEWIRES (INCLUDING THE PILOT 200 AND FIELDER XT GUIDEWIRES) AND MULTIPLE GUIDEWIRE MANEUVERS. THE CROSSBOSS WAS REMOVED AND THE VESSEL WAS PREPARED FOR STENT DEPLOYMENT USING MULTIPLE INFLATIONS AT UNKNOWN ATMS WITH A 1.5 AND 2.0 MM DILATATION BALLOONS. AT THIS TIME, A SMALL DISSECTION WAS NOTED IN THE DISTAL VESSEL, A STENT WAS DEPLOYED (UNKNOWN SIZE AT UNKNOWN ATMS) TO COVER THE DISSECTION. UPON INFLATION OF THE BALLOON ON THE STENT DELIVERY SYSTEM THE PATIENT'S B/P DROPPED SIGNIFICANTLY AND THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE REQUIRING ACLS PROTOCOLS TO STABILIZE. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS DISCHARGED FROM THE CATH LAB IN STABLE CONDITION. DR. SHARP FELT THAT THE PATIENT SUFFERED A VAGAL RESPONSE THAT RESULTED IN THE DECREASE OF HIS/HER B/P.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322269 BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER CROSSBOSS DQY BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFC M2000 B130860046

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention