BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGER II

    MDR report key: 796780 · Received December 12, 2006

    Report

    Report Number
    6000093-2006-02586
    Event Type
    Malfunction
    Date Received
    December 12, 2006
    Date of Event
    November 8, 2006
    Report Date
    November 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQC
    PMA / PMN Number
    k050863
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A CAROTID ARTERY ANGIOGRAPHY DIAGNOSTIC PROCEDURE, THE PACKAGE SEAL WAS COMPROMISED. THE CUSTOMER REPORTED THAT, "WHEN THE NURSE CAME TO OPEN THE STERILE PACK ON THIS IMAGER CATHETER, SHE FOUND A GAP IN THE SEAL, WHICH THEREFORE COMPROMISED THE STERILITY OF THE PRODUCT. ANOTHER CATHETER WAS USED INSTEAD. " THE DEVICE HAD NO CONTACT WITH THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMAGER II DQC, CATHETER, INTRAVASCULAR, DIAGNOSTIC DQC BOSTON SCIENTIFIC CORP. NA 0000039891

    Patients

    Seq Age Sex Outcome Treatment
    1 *