BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE MAX¿

    MDR report key: 2893654 · Received January 2, 2013

    Report

    Report Number
    2134265-2012-08102
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K972357
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 A STENTING TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. WHILE POST DILATING AN UNKNOWN STENT THIS BMQ/9-8/5.8/40 BALLOON WAS USED. ON THE FIRST INFLATION A CIRCUMFERENTIAL TEAR OCCURRED AND A PIECE OF THE BALLOON SHEARED OFF. THEY WERE ABLE TO SNARE THE BALLOON PIECE OUT OF THE PATIENT. THE PROCEDURE WAS THEN COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447 BLUE MAX¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001125630 0015468867

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention