BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7F ICRO INTRODUCER SET

    MDR report key: 4218519 · Received October 22, 2014

    Report

    Report Number
    1625425-2014-00033
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DRE
    PMA / PMN Number
    K780126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EXAMINATION. BASED ON THE PROBLEM DESCRIPTION , THE GUIDEWIRE WAS INTACT AFTER REMOVAL FROM THE PT. THEREFORE, IT IS PROBABLE THAT IT WAS INADVERTENTLY LEFT IN THE PT AFTER THE INITIAL SURGERY. PER THE INFO RECEIVED, THE INCIDENT DID NOT APPEAR TO BE PRODUCT RELATED. HOWEVER, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EXAMINATION AND THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE DOCTOR PERFORMED A BILATERAL RF VENOUS ABLATION ON (B)(6) 2014. THE PROCEDURE WENT WITHOUT DOCUMENTED INCIDENT. PATIENT PRESENTED TO (B)(6) URGENT CARE ON (B)(6) 2014 WITH AN INFLAMED RIGHT THIGH AND BROKEN DOWN INCISION WITH A WIRE STICKING OUT OF IT. URGENT CARE PHYSICIAN REMOVED THE WIRE AND BANDAGED. WIRE IS IN POSSESSION OF (B)(6) CENTER AND WAS VERIFIED TO BE AN INTACT 45 CM GUIDE-WIRE AND DOES NOT APPEAR TO BE PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671805 7F ICRO INTRODUCER SET MICRO INTRODUCER DRE ARGON MEDICAL DEVICES INC. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention