BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 21207177 · Received January 22, 2025

    Report

    Report Number
    9681834-2024-00263
    Event Type
    Injury
    Date Received
    January 22, 2025
    Report Date
    January 22, 2025
    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

    B3: DATE OF EVENT: REQUESTED, UNKNOWN. D4: LOT NUMBER: REQUESTED, UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. D4: UDI: N/A AT THIS PRODUCT CODE IS NOTE EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510(K): 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. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, ANALYSIS OF IT COULD NOT BE PERFORMED. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER SINCE THE INVOLVED 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. CAUSE OF OCCURRENCE/CONCLUSION: SINCE THE LOT INVOLVED IN THIS ISSUE WAS UNKNOWN, THE REVIEW OF MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS COULD NOT BE PERFORMED. IN ADDITION, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND THE INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: "DO NOT MANIPULATE OR WITHDRAW THE GLLDEWIRE THROUGH A METAL ENTRYNEEDLE 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 WIREFOR INITIAL PLACEMENT." TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE (PTGBD) PROCEDURE, RADIFOCUS GUIDEWIRE WAS KINKED WHEN IT WAS USED TO INSERT A SHEEN MAN DRAINAGE CATHETER. NO FRACTURE OR PEELING WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 23, 2024, FROM THE HEAD OF THE MEDICAL SAFETY MANAGEMENT OFFICE STATES THAT A METAL NEEDLE WAS USED WITH THE ACTUAL SAMPLE. AFTER THE PRGBD CATHETER WAS INITIALLY PLACED BUT BECAME DISLODGED, THE RADIFOCUS GUIDEWIRE WAS USED WITH A METAL NEEDLE TO REPOSITION THE CATHETER. WHEN THE GUIDEWIRE WAS BEING PULLED BACK, THE DISTAL END FRACTURED AND REMAINED IN THE PATIENT'S BODY. THE REMAINING PART WAS RETRIEVED THROUGH SURGICAL INTERVENTION. HE DID NOT RECOGNIZE THAT THE USE OF THIS PRODUCT WITH A METAL NEEDLE IS CONTRAINDICATED. THE PATIENT'S UNDERLYING PATHOLOGIES WERE ACUTE CHOLECYSTITIS AND CHOLELITHIASIS. CURRENTLY, THE PATIENT'S STATUS IS FINE. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590853 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GS35153 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other| R SHEEN MAN DRAINAGE CATHETER