BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 24683535 · Received March 25, 2026

    Report

    Report Number
    9681834-2026-00063
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 24, 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

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. 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 HAS BEEN RETURNED FOR EVALUATION. THE RETURNED DEVICE. - ACTUAL GUIDEWIRE. APPEARANCE CONFIRMATION. - THE WIRE STRAND HAD BEEN EXPOSED OVER APPROX.63MM TO 100MM (APPROX. 37 MM) FROM THE DISTAL END. APPEARANCE CONFIRMATION: - THE OUTER LAYER HAD PEELED OFF OVER HALF A CIRCUMFERENCE OVER APPROX. 63MM TO 100 MM FROM THE DISTAL END, AND THE WIRE STRAND HAD BEEN EXPOSED. - THE PEELED SURFACE OF THE OUTER LAYER WAS SMOOTH. - THE EDGE OF THE OUTER LAYER AT APPROXIMATELY 100 MM FROM THE DISTAL END WAS ARC-SHAPED AND HAD A GENTLE SLOPE. - THE OUTER LAYER HAD BEEN ABRADED AT APPROXIMATELY 65MM AND 102MM FROM THE DISTAL END. - NO ANOMALIES SUCH AS EXPOSURE OF THE WIRE STRAND OR ABRASION WERE FOUND IN APPEARANCE OF OTHER PARTS. DIMENSIONS: - THE OUTER DIAMETER (NORMAL PART): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. LENGTH OF DEFECT: - PART OF EXPOSED WIRE: APPROXIMATELY 63 MM TO 100 MM (APPROXIMATELY 37 MM) FROM THE DISTAL END - PEELED OUTER LAYER: APPROXIMATELY 43MM - IT WAS THOUGHT THAT THERE WAS NO DEFECT IN THE OUTER LAYER OF THE ACTUAL DEVICE. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER - SINCE THE LOT IS UNKNOWN, A HISTORY INVESTIGATION COULD NOT BE PERFORMED. - REGARDING THE INVOLVED PRODUCT, NO SIMILAR REPORTS ATTRIBUTABLE TO THE MANUFACTURING PROCESS WERE FOUND IN THE PAST TWO YEARS. SIMULATION TEST: A GUIDE WIRE WAS USED IN COMBINATION WITH A METAL NEEDLE. - THE OUTER LAYER WAS PEELED OFF OVER HALF A CIRCUMFERENCE, AND THE WIRE STRAND WAS EXPOSED. - THE PEELED SURFACE OF THE OUTER LAYER WAS SMOOTH. - THE EDGE AT THE DISTAL SIDE OF PEELED OUTER LAYER WAS STRAIGHT AND HAD A STEP. - THE EDGE AT THE PROXIMAL END OF PEELED OUTER LAYER WAS ARC-SHAPED AND HAD A GENTLE SLOPE. - THIS CONDITION SEEMED TO BE SIMILAR TO THAT OF THE ACTUAL DEVICE. BASED ON THE INVESTIGATION RESULTS, SINCE THE LOT IS UNKNOWN, IT WAS NOT POSSIBLE TO CONDUCT HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE/LOT#. IN THIS CASE, IT WAS THOUGHT THAT URETHANE BECAME PEELED OFF WHEN THE ACTUAL DEVICE WAS MANIPULATED IN THE DIRECTION OF REMOVAL WHILE IT WAS USED IN COMBINATION WITH A METAL NEEDLE, AND THE ACTUAL DEVICE CAME INTO CONTACT WITH THE METAL NEEDLE. FURTHERMORE, IT WAS THOUGHT THAT THERE WAS NO DEFECT IN THE OUTER LAYER OF THE ACTUAL DEVICE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT." 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 INFORMATION: IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSHEPATIC CHOLANGIAL DRAINAGE (PTCD), WHEN THE GUIDEWIRE WAS INSERTED IN CONJUNCTION WITH A METAL NEEDLE, THE URETHANE COAT ON THE SURFACE OOF THE GUIDEWIRE PEELED OFF. AFTER REVIEWING THE ACTUAL DEVICE REMOVED AND THE CONDITION OF THE PUNCTURED PART OF THE PATIENT, IT WAS DETERMINED THERE WAS NO RESIDUAL IN THE BODY AND CONFIRMED THERE WAS NO HARM ON THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746541 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GA35083 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown