BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE

    MDR report key: 22375291 · Received July 1, 2025

    Report

    Report Number
    9681834-2025-00118
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 1, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    UDI-DI
    04987350773197
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: SENIOR PROCUREMENT MANAGER. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A HISTORICAL INVESTIGATION OF THE PRODUCT WITH THE PRODUCT CODE/LOT NUMBER INVOLVED REVEALED NO ANOMALIES IN THE MANUFACTURING OR SHIPPING INSPECTION RECORDS. ADDITIONALLY, NO SIMILAR REPORTS WERE FOUND IN THE PAST COMPLAINT FILES. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. PLEASE REFER TO SECTION H10 FOR THE IMPORTER'S REPORT ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9 AND SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE IS NO LONGER AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. A HISTORICAL INVESTIGATION WAS CONDUCTED FOR THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT, INCLUDING REVIEW OF THE MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS FOR THE INVOLVED PRODUCT CODE AND LOT NUMBER. NO ANOMALIES WERE IDENTIFIED IN EITHER THE MANUFACTURING OR SHIPPING DOCUMENTATION. NO OTHER SIMILAR REPORTS HAVE BEEN IDENTIFIED FOR THIS PRODUCT CODE AND LOT NUMBER. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. HOWEVER, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO IDENTIFY THE CAUSE OF OCCURRENCE. ASHITAKA FACTORY ASSURES THE QUALITY OF THIS PRODUCT BY PERFORMING FOLLOWING INSPECTION AND CONTROL. THE OUTER DIAMETER OF WIRE IS CONTROLLED TO ASSURE ITS STRENGTH. BEFORE THE PACKAGING PROCESS, 100% VISUAL INSPECTION IS PERFORMED TO CONFIRM THAT THERE IS NO ANOMALY SUCH AS PEELING OF THE OUTER LAYER OR A SCRATCH. THE INSTRUCTIONS FOR USE (IFU) OF THIS PRODUCT INCLUDES THE FOLLOWING WARNING. IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE GLIDEWIRE WAS SEVERED DURING A NEURO PROCEDURE INSIDE THE PATIENT'S INTERNAL JUGULAR VEIN. THE SEVERED PARTS OF THE WIRE WERE SUCCESSFULLY RETRIEVED. THERE WAS NO REPORTED BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVELY AND DID NOT RESULT IN PATIENT INJURY OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 03 JUN 2025: TWO SEVERED PIECES WERE SNARED. THE PATIENT IS STABLE. A NAVICROSS, ANGLED, WAS USED WITH THE GLIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207415 GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA GR3508 241028 04987350773197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention