BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIWIRE PRESSURE GUIDE WIRE

    MDR report key: 20218986 · Received September 14, 2024

    Report

    Report Number
    3008363989-2024-00052
    Event Type
    Injury
    Date Received
    September 14, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 13, 2024
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    UDI-DI
    00845225003043
    PMA / PMN Number
    K192886
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. BLOCKS A4: NO INFORMATION AVAILABLE. BLOCKS B6: NO INFORMATION AVAILABLE. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS E1 & G2: COUNTRY IS THAILAND. BLOCK H3: THE OMNIWIRE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, THUS THE CAUSE COULD NOT BE ESTABLISHED. BLOCK H6: BASED ON THE PHOTO RECEIVED, THE GUIDEWIRE APPEARED TO BE STRETCHED. BLOCKS H7, H9, & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE IN A SLIGHTLY CALCIFIED DISTAL LAD. DURING PULLBACK, THE GUIDEWIRE BECAME STUCK INSIDE THE PATIENT. A NON-PHILIPS MICRO CATHETER WAS USED TO REMOVE THE GUIDEWIRE SUCCESSFULLY. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE OMNIWIRE WAS ENTRAPPED AND ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263580 OMNIWIRE PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 89185 0303073188 00845225003043

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male ASAHI: 6F GUIDE CATHETER| PHILIPS VOLCANO: INTRASIGHT SYSTEM| TERUMO: 7F INTRODUCER SHEATH