BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CATHETER SYSTEM

    MDR report key: 2891176 · Received December 21, 2012

    Report

    Report Number
    3004962788-2012-00051
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K102604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCATABLE WAS EVALUATED AND FOUND TO BE FUNCTIONAL. SUPERDIMENSION IS FILING THIS MDR OUT OF AN ABUNDANCE OF CAUTION DUE TO THE RISKS ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA. PROCEDURE RECORDINGS ARE STILL BEING EVALUATED AT THE TIME OF THIS FILING.

    Description of Event or Problem · 1

    SITE REPORTED TO SUPERDIMENSION ON (B)(6) 2012 THEY HAD A LOCATABLE GUIDE THAT WOULD NOT REGISTER WITH THE INREACH SYSTEM. THE SUPERDIMENSION PORTION OF THE CASE WAS ABANDONED AND THE SITE USED RADIAL PROBLEM TO GET TO THE LESION. THERE WAS NO REPORT OF PT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGE CATHETER SYSTEM GUIDE CATHETER JAK SUPERDIMENSION INC. 200-1 ES04906

    Patients

    Seq Age Sex Outcome Treatment
    1