BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGER II ANGIOGRAPHIC CATHETER

    MDR report key: 2122273 · Received June 13, 2011

    Report

    Report Number
    2134265-2011-02181
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K050863
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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 UNPACKING, A COMPROMISED STERILE PACKAGE BARRIER WAS NOTED. DURING UNPACKAGING OF A (B)(4) IMAGER II CATHETER A LITTLE RIP IN THE PLASTIC PACKAGING NEAR THE HUB OF THE DEVICE WAS OBSERVED AND THE STERILITY OF THE PRODUCT WAS SUSPECTED TO HAVE BEEN COMPROMISED. NO PATIENT CONTACT WAS INVOLVED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMAGER II ANGIOGRAPHIC CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE M001314050

    Patients

    Seq Age Sex Outcome Treatment
    1