BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA SELF-EXPANDING STENT SYSTEM

    MDR report key: 3013371 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01870
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE GUIDEWIRE STUCK IN THE SHEATH. THE PHYSICIAN DEPLOYED AN INNOVA BARE METAL STENT NORMALLY. WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE, IT STUCK IN THE SHEATH. THEREFORE, THE WHOLE SYSTEM WAS REMOVED TOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. NO ADDITIONAL INFORMATION IS AVAILABLE AS THE PHYSICIAN DID NOT REMEMBER THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115944 INNOVA SELF-EXPANDING STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK695

    Patients

    Seq Age Sex Outcome Treatment
    1