BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEL-AWY INTRO KIT 10F 14CM

    MDR report key: 262560 · Received February 16, 2000

    Report

    Report Number
    2182269-2000-00008
    Event Type
    Injury
    Date Received
    February 16, 2000
    Date of Event
    January 17, 2000
    Report Date
    February 16, 2000
    Manufacturer
    DAIG CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DESCRIBE EVENT OR PROBLEM: DURING A PACEMAKER LEAD IMPLANT, A SECTION OF THE DISTAL PORTION OF A 10F PEEL AWAY SHEATH SEPARATED, ENTERING THE PT. THE LEAD AND GUIDEWIRE WERE IN THE SHEATH AT THE TIME. A 4.5 INCH SECTION OF THE SHEATH WAS SURGICALLY REMOVED UTILIZING A RIGHT FEMORAL VENOUS SNARE APPROACH. THE PORTION REMOVED FROM THE PT APPEARED TO HAVE BEEN STRETCHED. THE PT WAS REPORTED TO BE IN STABLE CONDITION. THE HOSP'S RISK MGR DEPT HAS NOT RELEASED THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEL-AWY INTRO KIT 10F 14CM PEEL-AWAY INTRO KIT, 10F DYB DAIG CORP. 405120 99CR04

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention