BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA¿

    MDR report key: 3033508 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-02393
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: 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 COMPONENT OF THE DELIVERY SYSTEM DETACHED. THE "VERY TIGHT," APPROXIMATELY 89% STENOSED TARGET LESION WAS LOCATED IN THE VERY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. PRE-DILATION WAS PERFORMED WITH A 5X20X75 MUSTANG BALLOON CATHETER. THE 6X100X130 INNOVA STENT SYSTEM WAS THEN ADVANCED. THE STENT WAS DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. AFTER REMOVAL OF THE NON BSC .035 GUIDE WIRE, IT WAS NOTED THAT PART OF THE DELIVERY SYSTEM HAD DETACHED AND WAS CAUGHT ON THE GUIDE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136582 INNOVA¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939181061030 15547439

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR