BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 20180733 · Received September 10, 2024

    Report

    Report Number
    9681834-2024-00153
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 10, 2024
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: REQUESTED, UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. D10: CONCOMITANT MEDICAL PRODUCTS: ULTRASOUND-GUIDED ONE-STEP DRAINAGE SET S-TYPE (P/N 22110231) FROM HAKKO. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: UNKNOWN. G4: PMA/510(K): K923607, K926214. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, ANALYSIS OF IT COULD NOT BE PERFORMED. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. REGARDING THE INVOLVED PRODUCT TYPE, THERE HAVE BEEN NO REPORTED INCIDENTS ATTRIBUTABLE TO THE MANUFACTURING PROCESS IN THE PAST TWO YEARS. SINCE THE CORRECT LOT NUMBER 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 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 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 PRODUCTS (TMP) (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

    THE USER FACILITY REPORTED THAT DURING LIVER SURGERY ON (B)(6), A TORN PORTION OF GUIDEWIRE REMAINED IN THE TUMOR CYST ON THE LIVER RESECTION SURFACE. THE FRAGMENT WAS LEFT IN THE PATIENT. ABSCESS DRAINAGE WAS PERFORMED ON A PATIENT WHO HAD PREVIOUSLY UNDERGONE LIVER ABSCESS RESECTION AT ANOTHER HOSPITAL. THE ABSCESS WAS PUNCTURED USING A PTC NEEDLE, A GUIDEWIRE WAS INSERTED, AND DRAINAGE WAS SUCCESSFULLY CARRIED OUT. HOWEVER, DURING THE ATTEMPT TO REMOVE THE GUIDEWIRE FOR A CONFIRMATORY CONTRAST IMAGING, IT BECAME ENTANGLED WITH THE PTC NEEDLE, RESULTING IN A SECTION BREAKING OFF APPROXIMATELY 5 CM FROM THE TIP. THIS FRAGMENT REMAINED INSIDE THE LIVER ABSCESS, AND THE DECISION WAS MADE TO CONCLUDE THE PROCEDURE WITHOUT REMOVING IT. CONSIDERING THAT THE FRAGMENT WAS LODGED WITHIN THE ABSCESS, THE LIKELIHOOD OF IT MIGRATING TO ANOTHER AREA WAS LOW. THEREFORE, IT WAS INITIALLY DEEMED SAFE TO LEAVE IT IN PLACE WITHOUT IMMEDIATE CONCERNS. HOWEVER, ACCORDING TO THE FOLLOW-UP INFORMATION, THEY WERE PLANNING TO SURGICALLY REMOVE THE FRAGMENT DURING THE NEXT DRAINAGE PROCEDURE. CURRENTLY, THERE ARE NO HEALTH RISKS TO THE PATIENT, AND THE CONDITION OF THE LIVER IS SHOWING IMPROVEMENT WITH THE DRAINAGE TREATMENT. CURRENTLY, THERE IS NO RISK TO THE PATIENT'S HEALTH. THE CONDITION OF THE LIVER WAS SHOWING IMPROVEMENT WITH THE DRAINAGE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252401 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SONOGUIDE PTC NEEDLE TYPE-B 18G FROM HAKKO| ULTRASOUND-GUIDED ONE-STEP DRAINAGE SET S-TYPE