BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 23999628 · Received January 7, 2026

    Report

    Report Number
    9681834-2025-00242
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 12, 2025
    Report Date
    January 7, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. G4: 510(K) NUMBER: K923607, K926214. RETURNED DEVICE ONE ACTUAL GUIDEWIRE. APPEARANCE CONFIRMATION OF THE ACTUAL DEVICE CLEAR DEPOSIT WAS OBSERVED ALONG APPROXIMATELY 482MM TO 506MM FROM THE DISTAL END. IT WAS THOUGHT THAT THIS DEPOSIT WAS RECOGNIZED AS A FINE SPLIT IN THE OUTER LAYER. NO ANOMALY SUCH AS ABRASION WAS FOUND IN OTHER PARTS. FT-IR ANALYSIS THE CLEAR DEPOSIT WAS QUALITATIVELY ANALYZED USING FT-IR. THE PEAK WAS SIMILAR TO THAT OF THE ETFE. FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY METHOD): *FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY): AN ANALYSIS METHOD USED TO IDENTIFY THE MOLECULAR STRUCTURE OF AN OBJECT BY ANALYZING THE SPECTRUM OBTAINED FROM INFRARED RADIATION APPLIED TO THE MEASUREMENT TARGET. SINCE THE WAVELENGTH OF THE INFRARED RADIATION ABSORBED IS NEARLY DISTINCTIVE FOR EACH OBJECT, IT IS POSSIBLE TO CONDUCT QUALITATIVE ANALYSIS OF THE OBJECT BY COMPARING IT WITH A STANDARD SAMPLE OF INFRARED ABSORPTION SPECTRUM. COMBINATION TEST A FACTORY-RETAINED BALLOON CATHETER WAS INSERTED FROM THE PROXIMAL END OF THE ACTUAL GUIDEWIRE. IT WAS NOT POSSIBLE TO BE INSERTED AT APPROXIMATELY 506MM FROM THE DISTAL END OF THE ACTUAL GUIDEWIRE (AT THE DEPOSIT ADHERED PART). APPEARANCE CONFIRMATION OF THE ACTUAL DEVICE AFTER REMOVING THE DEPOSIT NO ANOMALY SUCH AS ABRASION WAS FOUND ON THE DEPOSIT ADHERED PART. COMBINATION TEST AFTER REMOVING DEPOSIT. A FACTORY-RETAINED BALLOON CATHETER WAS INSERTED FROM THE PROXIMAL END OF THE ACTUAL GUIDEWIRE. IT COULD BE INSERTED WITHOUT RESISTANCE OVER THE ENTIRE LENGTH. DIMENSIONS IT MET THE FACTORY'S SPECIFICATIONS AND NO ANOMALY WAS FOUND OVER THE ENTIRE LENGTH. CONFIRMATION OF SLIDABILITY SLIDABILITY OF THE ACTUAL GUIDEWIRE (NORMAL PART) WAS CONFIRMED WITH HAND SENSORY. NO ANOMALY WAS FOUND OVER THE ENTIRE LENGTH. DYEING CONFIRMATION AFTER THE HYDROPHILIC COATING LAYER WAS DYED, THE APPEARANCE WAS CONFIRMED WITH UV LIGHT. IT WAS DYED OVER THE ENTIRE LENGTH, AND NO PEELING OF THE HYDROPHILIC COAT WAS OBSERVED. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE/LOT NUMBER NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO SIMILAR EVENT WAS FOUND IN THE PAST COMPLAINT FILE. TYW SURVEY RESULTS BEFORE THE PACKAGING PROCESS, 100 % VISUAL INSPECTION IS PERFORMED AND IT IS POSSIBLE TO DETECT FOREIGN SUBSTANCES ADHERING TO THE GUIDEWIRE M. IT WAS CONFIRMED THAT THERE IS NO ETFE IN THE PROCESS AND IN THE MATERIALS USED. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. FROM THE INVESTIGATION RESULTS, IT IS CONSIDERED THAT THE CLEAR DEPOSIT WAS ETFE, AND THAT THIS DEPOSIT WAS RECOGNIZED AS THE FINE SPLIT IN THE OUTER LAYER. IN ADDITION, IT WAS CONSIDERED EXTREMELY UNLIKELY THAT ETFE WOULD HAVE BEEN WRAPPED AROUND THIS PRODUCT BEFORE IT WAS SHIPPED FROM THE FACTORY. SINCE NO ANOMALY WAS FOUND IN THE DIMENSIONS AND SLIDABILITY, IT WAS BELIEVED THAT THERE IS NO ANOMALY IN THE ACTUAL DEVICE. BASED ON THE SHAPE OF THE ETFE, IT IS POSSIBLE THAT THIS IS PART OF THE CONCOMITANT DEVICE, BUT THE CONCOMITANT DEVICE WAS NOT RETURNED AND AN ANALYSIS OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY. RELEVANT IFU REFERENCE: "DIRECTIONS FOR USE 2. FILL THE HOLDER WITH HEPARINIZED PHYSIOLOGICAL SALINE SOLUTION THROUGH THE HUB OF THE HOLDER USING A SYRINGE." 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 MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THIS PRODUCT WAS USED IN A SHUNT CASE. AFTER THE PRODUCT WAS INSERTED INTO THE BODY, UPON DELIVERING THE BALLOON CATHETER, THE CATHETER COULD NOT ADVANCE. THE PRODUCT WAS REMOVED AND INSPECTED, AND THE URETHANE OF THE WIRE WAS OBSERVED TO BE SPLIT. SINCE THE PROCEDURE WAS DONE AS USUAL, IT CANNOT BE DENIED THAT THIS PROBLEM IS ATTRIBUTED TO THE PRODUCT. IT IS REPORTED THAT NO FRAGMENT REMAINED IN THE BODY AS IT WAS NOT COMPLETELY BROKEN OFF. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59514 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GA35153 241225YA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown