BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    MDR report key: 11665986 · Received April 14, 2021

    Report

    Report Number
    2522007-2021-00015
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 17, 2021
    Report Date
    February 15, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRB
    PMA / PMN Number
    K970690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: STYLET, CATHETER. PROCODE: DRB. PMA/510(K): K970690. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    AFTER UNSUCCESSFUL TLE PROCEDURE, LEAD AND LOCKING STYLET (LR-OFA01) WERE CUT AND FIXATED IN PATIENT. APPROXIMATELY 6 MONTHS LATER; PATIENT COMPLAINED OF PAIN IN SHOULDER. AN X-RAY SUBSEQUENTLY REVEALED PIECES OF UNIDENTIFIED WIRE LOCATED WITHIN PATIENT¿S SHOULDER. THE FAILED EXTRACTION OF THE LIBERATOR LOCKING STYLET RESULTED IN THE TUBE BEING CAPPED AND FAILED REMOVAL; CREATING THE SMALL POSSIBILITY THAT THE TUBE EMIGRATED TO ITS CURRENT LOCATION. THE REMOVED WIRES ARE BEING SENT BACK TO FOR CONFIRMATION THAT THEY ARE INDEED LIBERATOR PARTS. NO PARTS OF DEVICE REMAINED IN PATIENT¿S BODY AFTER PROCEDURE AND NO ADDITIONAL PROCEDURES TOOK PLACE DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561457 LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET DRB COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Required Intervention