BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGE¿

    MDR report key: 2872393 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07496
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT WAS INDICATED THAT THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE, VESSEL PERFORATION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN PERFORMED AN ATHERECTOMY USING THE ROTABLATOR SYSTEM. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. THE ROTABLATOR SYSTEM WAS REMOVED. THE PHYSICIAN THEN INFLATED A 12MM X 2.50MM EMERGE BALLOON CATHETER IN THE TARGET LESION. UPON REMOVAL OF THE BALLOON CATHETER A PERFORATION WAS NOTED. THE PROCEDURE WAS COMPLETED BY IMPLANTING A 2.5X8MM AND A 2.75X20MM PROMUS ELEMENT STENTS TO TREAT THE PERFORATION. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918912250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROTAWIRE