BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE GT

    MDR report key: 25331005 · Received May 29, 2026

    Report

    Report Number
    9681834-2026-00117
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 29, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI NO. N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: RADIOGRAPHER. G4: 510(K) NUMBER: K955801, K170417. 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. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER: NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    TERUMO CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING COMPLEX EMBOLIZATION, AND WHILST ACCESSING THE TARGET VESSEL, THE WIRE SNAPPED INSIDE THE GUIDING CATHETER. A LARGE PORTION OF THE WIRE HAS BEEN RETAINED INSIDE THE PATIENT, ALTHOUGH THIS DID NOT AFFECT THE PROCEDURE OUTCOME. THE REST OF THE WIRE WAS REMOVED, AND FURTHER EMBOLIZATION PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026: THERE IS STILL A PART LEFT WITHIN THE PATIENT ABOUT 2-3 CM'S OF THE WIRE CAME BROKE OFF. AN ATTEMPT WAS MADE TO RETRIEVE IT USING A SNARE HOWEVER, IT WAS QUITE AN ACUTE BLEED AND IT WAS IT WAS IN A SEGMENT OF THE HEPATIC ARTERY WHICH THEY COMPLETELY FILLED WITH ONYX SO IT WILL NOT EVER MOVE AS IT IS COMPLETELY INCASED WITHIN THE ONYX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232632 GLIDEWIRE GT WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RG*GA1620FM 250916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O BOSTRON SCIENTIFIC DIRECTION 2.1F MC.| ONYX.