BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSBOSS CATHETER

    MDR report key: 3892233 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03634
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. A CROSSBOSS CATHETER WAS USED DURING A CHRONIC TOTAL OCCLUSION (CTO) PROCEDURE OF THE 100% STENOSED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CROSSBOSS CATHETER WENT INTO A SIDE BRANCH AND CAUSED A SMALL PERFORATION IN THAT VESSEL. THE PHYSICIAN WAS ABLE TO CLOSE OFF THE HOLE IN THAT VESSEL WITH BALLOON INFLATION; HOWEVER, THE PATIENT EXPERIENCED CHEST PAIN WHEN THE BALLOON WAS INFLATED. THE PHYSICIAN PROVIDED MEDICINE TO THE PATIENT FOR THE CHEST PAIN. THE PHYSICIAN THEN EMPTIED BLOOD FLOW AND REVERSED COAGULATION, WHICH STOPPED THE HOLE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368424 CROSSBOSS CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749M2000A0 B133370203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention