BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 24570086 · Received March 11, 2026

    Report

    Report Number
    9681834-2026-00046
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 11, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: COMMON DEVICE NAME: LAPAROSCOPE, GENERAL & PLASTIC SURGERY. D2B: PRODUCT CODE: GCJ. D4: LOT NUMBER: REQUESTED, UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. 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 H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER THE ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER - SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. - REGARDING THE INVOLVED PRODUCT, THERE HAVE BEEN NO SIMILAR INCIDENTS ATTRIBUTABLE TO THE MANUFACTURING PROCESS IN THE PAST TWO YEARS. SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS COULD NOT BE INVESTIGATED. IN ADDITION, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND THE ANALYSIS OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: 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. 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 RECEIVED THE FOLLOWING REPORTED INFORMATION. THE PATIENT UNDERWENT ANGIOGRAPHY TWICE DURING HOSPITALIZATION (JANUARY 13, JANUARY 19) AND IT WAS IDENTIFIED THAT THE FOREIGN MATTER WAS LEFT INSIDE THE PATIENT AFTER THE SECOND PROCEDURE. AFTER THE FIRST ANGIOGRAPHY (JANUARY 13): NO FOREIGN MATTERS WERE OBSERVED. AFTER THE SECOND ANGIOGRAPHY (JANUARY 19): A FOREIGN MATTER WAS FOUND IN THE VESSEL NEAR BACK OF THE RIGHT EYE, AND IT WAS ALSO IDENTIFIED WITH CT. WHEN THE DOCTOR, WHO PERFORMED THE SECOND ANGIOGRAPHY, TOOK OFF THE CATHETER USED IN THE ANGIOGRAPHY, HE ATTEMPTED TO REINSERT THE GUIDEWIRE AND FOUND THE ANOMALY THAT THE THIN LINE LIKE BEARD WAS AT THE DISTAL END OF THE GUIDEWIRE. HOWEVER, HE DETERMINED IT OCCURRED OUTSIDE THE PATIENT AND CONTINUED THE PROCEDURE REPLACING IT WITH A NEW GUIDEWIRE RADIFOCUS. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626914 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GA35153

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Other