BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUGE

    MDR report key: 19032661 · Received April 3, 2024

    Report

    Report Number
    2124215-2024-20226
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 9, 2024
    Report Date
    April 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729169963
    PMA / PMN Number
    K143587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: H6 DEVICE CODES: A040101 FRACTURE CORRECTED TO A0501 DETACHMENT OF DEVICE OR DEVICE COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 182 CM LUGE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING REMOVAL, THE TIP OF THE WIRE WAS BROKEN AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 182 CM LUGE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING REMOVAL, THE TIP OF THE WIRE BROKE OFF IN THE DISTAL LAD AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689370 LUGE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 2746 0033214000 08714729169963

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other