BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSBOSS CATHETER

    MDR report key: 3870089 · Received June 12, 2014

    Report

    Report Number
    2134265-2014-03256
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DURING AN ANGIOPLASTY PROCEDURE A VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. THE CROSSBOSS WAS SUCCESSFUL; HOWEVER, A VESSEL PERFORATION OCCURRED WITH DURING BALLOON INFLATION DISTAL TO THE CHRONIC TOTAL OCCLUSION. THE PERFORATION WAS TREATED BY REINFLATING THE BALLOON AND PLACEMENT OF EMBOLIZATION COILS. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348626 CROSSBOSS CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749M2000A0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention