BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA SURGICAL PROBE

    MDR report key: 525065 · Received May 14, 2004

    Report

    Report Number
    2939222-2004-00018
    Event Type
    Injury
    Date Received
    May 14, 2004
    Date of Event
    January 1, 2001
    Report Date
    April 15, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE INFO ON THIS MEDWATCH REPORT WAS OBTAINED IN ANNALS OF THORACIC SURGERY 2003; 76: 1291-3, IDENTIFIED IN A LITERATURE SEARCH CONDUCTED 04/2004. THE EXACT DATE OF THE PROCEDURE AND SUBSEQUENT IDENTIFICATION OF THE INJURY ARE UNKNOWN. HOWEVER, INITIAL FOLLOW-UP WITH THE PHYSICIAN REVEALED THE INJURY WAS IDENTIFIED APPROX 2 YEARS AGO. FURTHER FOLLOW-UP IS IN PROGRESS. IF ADDITIONAL INFO IS OBTAINED, FOLLOW-UP REPORTS WILL BE SUBMITTED. CIRCUMFLEX ARTERY STENOSIS WAS IDENTIFIED IN THE PATIENT ONE YEAR AFTER INTROPERATIVE RF ABLATION WITH A THERMALINE PROBE TO TREAT PERMANENT ARTIAL FIBRILLATION. THE PATIENT PRESENTED WITH ACUTE PULMONARY EDEMA AND SEVERE ANGINA 1 YEAR AFTER AN UNEVENTFUL RECOVERY. THE STENOSIS WAS SUCCESSFULLY TREATED WITH ANGIOPLASTY. THE PHYSICIAN REPORTED THE PATIENT IS HEALTHY AND FOLLOWED REGULARLY. THE FACILITY HAS MODIFIED THEIR PROTOCOL TO USE COLD CARDIOPLEGIA AND MOVED THE LOCATION OF THE LESION, POWER OUTPUT HAS ALSO BEEN REDUCED FROM A TARGET OF 150 W TO 100 W.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBRA SURGICAL PROBE SURGICAL ABLATION SYSTEM GEI EP TECHNOLOGIES, INC. 15927 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention