BEUDAMED
    FDA Adverse Event Other Summary report: N

    CROSSBOSS CTO CATHETER

    MDR report key: 2526500 · Received October 27, 2009

    Report

    Report Number
    3007210311-2009-00001
    Event Type
    Other
    Date Received
    October 27, 2009
    Date of Event
    September 28, 2009
    Report Date
    October 21, 2009
    Manufacturer
    BRIDGEPOINT MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K081130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS CLASSIFIED AS "OTHER: INTERVENTION REQUIRED" BECAUSE PERFORATIONS ARE COMMONLY ADDRESSED IN CTO PROCEDURES BY INFLATION OF A BALLOON CATHETER AND REVERSE HEPARIN WITH NO ADVERSE CONSEQUENCE TO THE PT. PERFORATION IS A POSSIBLE COMPLICATION THAT IS CAPTURED IN THE CROSSBOSS CATHETER RISK ASSESSMENTS AND IS LISTED IN THE INSTRUCTIONS FOR USE. THIS EVENT OCCURRED IN THE (B)(4) CLINICAL STUDY AND IS REPORTED VIA MDR BECAUSE OF THE SIMILARITY IN THE STUDY DEVICE WITH THE COMMERCIALLY APPROVED CROSSBOSS CATHETER. OF NOTE, SINCE THIS EVENT OCCURRED DURING THE FAST-CTOS STUDY, BRIDGEPORT MEDICAL PERSONNEL WERE PRESENT DURING THE INTERVENTION. (B)(6) PERSONNEL DID NOT WITNESS ANY ANGIOGRAPHIC EVIDENCE OF A PERFORATION DURING THE USE OF THE CROSSBOSS CATHETER AND THE PHYSICIAN DID NOT RECORD THE CONTRAST EXTRAVATION INTO THE PERICARDIUM. THIS EVENT IS CURRENTLY BEING REVIEWED BY THE DATA SAFETY AND MONITORING BOARD ASSOCIATED WITH THE STUDY TO DETERMINE THE REQUIRED STUDY REPORTING NECESSARY FOR THE FAST-CTOS STUDY.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS INTERVENTION IN AN ATTEMPT TO CROSS A CHRONIC TOTAL OCCLUSION (CTO) OF A RIGHT CIRCUMFLEX CORONARY ARTERY, A PERFORATION OF THE ARTERY WAS OBSERVED DURING USE OF THE CROSSBOSS CTO CATHETER. DYE EXTRAVASATION WAS OBSERVED BY THE PHYSICIAN IN THE PERICARDIUM WITH IMMEDIATE WASHOUT. PROTAMINE WAS GIVEN TO REVERSE HEPARIN-BASED ANTICOAGULATION AND A PROLONGED INFLATION OF AN ANGIOPLASTY BALLOON SEALED THE PERFORATION. THE PT EXPERIENCED NO ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSBOSS CTO CATHETER NONE DQY BRIDGEPOINT MEDICAL INC. M-2000 BP20091890020

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention